Canada Gazette, Part I, Volume 147, Number 44: GOVERNMENT NOTICES

November 2, 2013

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice with respect to reporting of greenhouse gases (GHGs) for 2013

Notice is hereby given, pursuant to subsection 46(1) of the Canadian Environmental Protection Act, 1999 (the Act), that, with respect to emissions of GHGs identified in Schedule 1 to this notice and for the purpose of conducting research, creating an inventory of data, formulating objectives and codes of practice, issuing guidelines or assessing or reporting on the state of the environment, any person who operates a facility described in Schedule 3 to this notice during the 2013 calendar year, and who possesses or who may reasonably be expected to have access to information described in Schedule 4 to this notice, shall provide the Minister of the Environment with this information no later than June 1, 2014.

Information on GHG emissions requested under this notice shall be submitted to

Minister of the Environment
Pollutant Inventories and Reporting Division
Environment Canada
Fontaine Building, 8th Floor
200 Sacré-Cœur Boulevard
Gatineau, Quebec
K1A 0H3

Enquiries concerning this notice shall be addressed to

Pollutant Inventories and Reporting Division
Environment Canada
Fontaine Building, 8th Floor
200 Sacré-Cœur Boulevard
Gatineau, Quebec
K1A 0H3
Telephone: 819-994-0684
Fax: 819-953-2347
Email: ges-ghg@ec.gc.ca

This notice applies to the calendar year 2013. Pursuant to subsection 46(8) of the Act, persons subject to this notice shall keep copies of the required information, together with any calculations, measurements and other data on which the information is based, at the facility to which the calculations, measurements and other data relate, or at the facility’s parent company, located in Canada, for a period of three years from the date the information is required to be submitted. Where the person chooses to keep the information required under the notice, together with any calculations, measurements and other data, at the facility’s parent company in Canada, that person shall inform the Minister of the civic address of that parent company.

If a person who operates a facility, with respect to which information was submitted in response to the Notice with respect to reporting of greenhouse gases (GHGs) for 2012, determines that the facility is not required to provide the information set out in Schedule 4 of this notice, the person shall notify the Minister of the Environment that the facility does not meet the criteria set out in Schedule 3 of this Notice no later than June 1, 2014.

The Minister of the Environment intends to publish greenhouse gas emission totals by gas by facility. Pursuant to section 51 of the Act, any person subject to this notice who provides information in response to this notice may submit, with their information and no later than their deadline for submission, a written request that it be treated as confidential based on the reasons set out in section 52 of the Act. The person requesting confidential treatment of the information shall indicate which of the reasons in section 52 of the Act applies to their request. Nevertheless, the Minister may disclose, in accordance with subsection 53(3) of the Act, information submitted in response to this notice. Every person to whom a notice is directed shall comply with the notice. A person who fails to comply with the Act is subject to the offense provision.

DAVID MORIN
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

SCHEDULE 1

Greenhouse Gases

Table 1: Greenhouse gases subject to mandatory reporting
  Greenhouse Gas Formula CAS Registry Number (see reference †) 100-year Global Warming Potential (GWP)
1. Carbon dioxide CO2 124-38-9 1
2. Methane CH4 74-82-8 25
3. Nitrous oxide N2O 10024-97-2 298
4. Sulphur hexafluoride SF6 2551-62-4 22 800
Hydrofluorocarbons (HFCs)
5. HFC-23 CHF3 75-46-7 14 800
6. HFC-32 CH2F2 75-10-5 675
7. HFC-41 CH3F 593-53-3 92
8. HFC-43-10mee C5H2F10 138495-42-8 1 640
9. HFC-125 C2HF5 354-33-6 3 500
10. HFC-134 C2H2F4 (Structure: CHF2CHF2) 359-35-3 1 100
11. HFC-134a C2H2F4 (Structure: CH2FCF3) 811-97-2 1 430
12. HFC-143 C2H3F3 (Structure: CHF2CH2F) 430-66-0 353
13. HFC-143a C2H3F3 (Structure: CF3CH3) 420-46-2 4 470
14. HFC-152a C2H4F2 (Structure: CH3CHF2) 75-37-6 124
15. HFC-227ea C3HF7 431-89-0 3 220
16. HFC-236fa C3H2F6 690-39-1 9 810
17. HFC-245ca C3H3F5 679-86-7 693
Perfluorocarbons (PFCs)
18. Perfluoromethane CF4 75-73-0 7 390
19. Perfluoroethane C2F6 76-16-4 12 200
20. Perfluoropropane C3F8 76-19-7 8 830
21. Perfluorobutane C4F10 355-25-9 8 860
22. Perfluorocyclobutane c-C4F8 115-25-3 10 300
23. Perfluoropentane C5F12 678-26-2 9 160
24. Perfluorohexane C6F14 355-42-0 9 300

Reference † The Chemical Abstracts Service (CAS) Registry Number is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

SCHEDULE 2

Definitions

1. The following definitions apply to this notice and its schedules:

“biomass” means plants or plant materials, animal waste or any product made of either of these. Biomass includes wood and wood products, charcoal, and agricultural residues and wastes (including organic matter such as trees, crops, grasses, tree litter, or roots); that portion of biologically derived organic matter in municipal and industrial wastes; landfill gas; bio-alcohols; black liquor; sludge gas; and animal- or plant-derived oils. (biomasse)

“carbon dioxide equivalent (CO2 eq.)” means a unit of measure used to allow the addition of or the comparison between gases that have different global warming potentials (GWPs). (see footnote 1) [équivalent en dioxyde de carbone (équivalent CO2)]

“CAS Registry Number” means the Chemical Abstracts Service Registry Number. (see footnote 2) (numéro d’enregistrement CAS)

“CO2 emissions from biomass decomposition” means releases of CO2 resulting from aerobic decomposition of biomass. (émissions de CO2 provenant de la décomposition de la biomasse)

“contiguous facility” means all buildings, equipment, structures and stationary items that are located on a single site or on contiguous or adjacent sites and that are owned or operated by the same person and that function as a single integrated site and includes wastewater collection systems that discharge treated or untreated wastewater into surface waters. (installation contiguë)

“direct emissions” means releases from sources that are located at the facility. (émissions directes)

“facility” means a contiguous facility, a pipeline transportation system, or an offshore installation. (installation)

“flaring emissions” means controlled releases of gases from industrial activities, from the combustion of a gas and/or liquid stream produced at the facility not for the purpose of producing energy, including releases from waste petroleum incineration, hazardous emission prevention systems (whether in pilot or active mode), well testing, natural gas gathering systems, natural gas processing plant operations, crude oil production, pipeline operations, petroleum refining and chemical fertilizer and steel production. (émissions de torchage)

“fugitive emissions” means uncontrolled releases of gases from industrial activities, other than releases that are venting or flaring emissions, including those releases resulting from the production, processing, transmission, storage and use of solid, liquid or gaseous fuels. (émissions fugitives)

“GHGs” means greenhouse gases. (GES)

“GWP” means global warming potential. (PRP)

“HFCs” means hydrofluorocarbons. (HFC)

“industrial process emissions” means releases from an industrial process that involves chemical or physical reactions other than combustion, and the purpose of which is not to supply energy. (émissions liées aux procédés industriels)

“offshore installation” means an offshore drilling unit, production platform or ship, or sub-sea installation and that is attached or anchored to the continental shelf of Canada in connection with the exploitation of oil or gas. (installation extracôtière)

“on-site transportation emissions” means any direct releases from machinery used for the on-site transportation of substances, materials or products used in the production process. (émissions liées au transport sur le site)

“PFCs” means perfluorocarbons. (PFC)

“pipeline transportation system” means all pipelines that are owned or operated by the same person within a province or territory and that transport processed natural gas and their associated installations including storage installations but excluding straddle plants or other processing installations. (gazoducs)

“reporting company” means a person who operates one or more facilities that meet the reporting threshold as set out in Schedule 3 of this notice. (société déclarante)

“stationary fuel combustion emissions” means releases from non-vehicular combustion sources, in which fuel is burned for the purpose of producing energy. (émissions de combustion stationnaire de combustible)

“venting emissions” means controlled releases to the atmosphere of a waste gas, including releases of casing gas, a gas associated with a liquid (or solution gas), treater, stabilizer or dehydrator off-gas, blanket gas, and releases from pneumatic devices which use natural gas as a driver, and from compressor start-ups, pipelines and other blowdowns, and metering and regulation station control loops. (émissions d’évacuation)

“waste emissions” means releases that result from waste disposal sources at a facility that include landfilling of solid waste, flaring of landfill gas and waste incineration. (émissions des déchets)

“wastewater emissions” means releases that result from wastewater and wastewater treatment at a facility. (émissions des eaux usées)

SCHEDULE 3

Criteria for Reporting

Persons subject to this notice

1. (1) All persons who operate a facility that emits 50 000 tonnes of carbon dioxide equivalent (50 kt CO2 eq.) or more (the “reporting threshold”) of the GHGs listed in Table 1 of Schedule 1 in the 2013 calendar year shall be subject to the reporting requirements set out in this notice.

(2) If the person who operates a facility as described in this Schedule changes during the 2013 calendar year, the person who operates the facility, as of December 31, 2013, shall report for the entire 2013 calendar year by June 1, 2014. If operations at a facility are terminated during the 2013 calendar year, the last operator of that facility is required to report for the portion of the 2013 calendar year during which the facility was in operation by June 1, 2014.

2. (1) A person subject to this notice shall determine whether a facility meets or exceeds the reporting threshold described in section 1, using the following equation and the criteria set out in subsections (2) to (4) of this section:

Formula

where

E = total emissions of a particular gas or gas species from the facility in the calendar year 2013, expressed in tonnes

GWP = global warming potential of the same gas or gas species

i = each emission source

(2) A person subject to this notice shall quantify emissions of each HFC and PFC substance on Schedule 1 separately and then multiply the result for each of these substances by the global warming potential set out in Table 1 of Schedule 1 for that substance.

(3) For the purposes of subsection (1), a person subject to this notice shall not include CO2 emissions from combustion of biomass in the determination of total emissions. The person shall quantify and report CO2 emissions from the combustion of biomass as part of the greenhouse gas emissions information that is required in paragraph 2(e) of Schedule 4 of this notice.

(4) For the purposes of subsection (1), a person subject to this notice shall not include CO2 emissions from biomass decomposition in the determination of total emissions.

3. A person submitting a report in respect of a facility that meets the emission criteria above shall use the applicable quantification methods for estimating emissions set out in Section E of the Updated UNFCCC [United Nations Framework Convention on Climate Change] reporting guidelines on annual inventories following incorporation of the provision of decision 14/CP.11 contained in FCCC/SBSTA/2006/9.

SCHEDULE 4

Reportable Information

1. A person subject to this notice shall report the following information for each facility that meets the reporting threshold set out in Schedule 3 of this notice:

  • (a) the reporting company’s legal and trade name (if any), and federal business number (assigned by the Canada Revenue Agency) and their Dun and Bradstreet (D-U-N-S) number (if any);
  • (b) the facility name (if any) and the address of its physical location;
  • (c) the latitude and longitude coordinates of the facility, other than a pipeline transportation system;
  • (d) the six-digit North American Industry Classification System (NAICS) Canada code;
  • (e) the National Pollutant Release Inventory identification number (if any);
  • (f) the name, position, mailing and civic address, email address and telephone number of the person submitting the information that is required under this notice;
  • (g) the name, position, mailing address, email address and telephone number of the public contact (if any);
  • (h) the name, position, mailing and civic address, email address and telephone number of the authorized signing officer signing the Statement of Certification pursuant to section 4; and
  • (i) the legal names of the Canadian parent companies (if any), their civic addresses, their percentage of ownership of the reporting company (where available), their federal business number and their Dun and Bradstreet (D-U-N-S) number (if any).

2. For each of the GHGs listed in Table 1 of Schedule 1, a person subject to this notice shall report the following information for each facility that meets the reporting threshold set out in Schedule 3 of this notice:

  • (a) the total quantity in tonnes of direct emissions of carbon dioxide, in each of the following source categories: stationary fuel combustion emissions, industrial process emissions, venting emissions, flaring emissions, fugitive emissions, on-site transportation emissions, waste emissions, and wastewater emissions. The person subject to this notice shall not include CO2 emissions from biomass combustion in the above source categories, but shall report these emissions separately;
  • (b) the total quantity in tonnes of direct emissions of methane and nitrous oxide, in each of the following source categories: stationary fuel combustion emissions, industrial process emissions, venting emissions, flaring emissions, fugitive emissions, on-site transportation emissions, waste emissions, and wastewater emissions. The person subject to this notice shall include CH4 and N2O emissions from biomass combustion in the above source categories;

Note: Table 2, below, provides a table for the reporting of these gases.

Table 2: Table for reporting certain GHGs by source category
Gas Source Categories
Stationary Fuel Combustion Industrial Process Venting Flaring Fugitive On-site Transportation Waste Wastewater
Carbon dioxide (excluding that from biomass combustion, which is to be reported further to subsection (e))                
Methane                
Nitrous oxide                
Total                
  • (c) in instances where industrial process emissions are produced in combination with emissions from fuel combusted for energy purposes, the person subject to this notice shall report the emissions according to the purpose of the activity : if the purpose of the activity is energy production, the emissions shall be reported as stationary fuel combustion emissions; however, if the purpose of the activity is an industrial process rather than energy production, the emissions shall be reported as industrial process emissions; (see footnote 3)
  • (d) the total quantity in tonnes of direct emissions of sulphur hexafluoride and each hydrofluorocarbon and perfluorocarbon listed on Schedule 1, from industrial processes and industrial product use;
  • (e) the total quantity in tonnes of CO2 from biomass combustion; and
  • (f) the method of estimation used to determine the quantities reported pursuant to paragraphs (a), (b), (d) and (e) chosen from monitoring or direct measurement, mass balance, emission factors, or engineering estimates.

3. CO2 emissions from biomass decomposition are not to be reported.

4. The reported information is to include a Statement of Certification, signed by an authorized signing officer, indicating that the information submitted is true, accurate and complete.

5. If the reported information is subject to a request for confidentiality pursuant to section 51 of the Act, the person subject to this notice shall identify which information is subject to the request and the reasons for the request in accordance with section 52 of the Act.

EXPLANATORY NOTE

(This note is not part of the notice.)

In March of 2004, the Government of Canada initiated a phased approach to the collection of greenhouse gas emissions and related information. The program was launched through the publication of the first Canada Gazette notice in March 2004, which set out basic reporting requirements. This notice is the tenth in a series of notices requiring the reporting of greenhouse gas emissions. This notice is part of Canada’s effort to develop, through a collaborative process with provinces and territories, a harmonized reporting system that will meet the information needs of all levels of government, provide Canadians with reliable and timely information on GHG emissions and support the development of regulations.

Reporting requirements on greenhouse gas emissions outlined in this notice are now collected via Environment Canada’s Single Window (EC SW) system that was launched in March 2010. The EC SW system currently collects data for Environment Canada’s Greenhouse Gas Emissions Reporting Program, and GHG reporting for British Columbia, Alberta, and Ontario, the National Pollutant Release Inventory and its partners and various other partner programs. The EC SW system is currently being considered for GHG reporting by other provinces. The use of a single system for reporting on GHG emissions helps to reduce the reporting burden on industry, and the overall cost to Government. The system requires industry to submit information that is common to multiple jurisdictions once, but also accommodates reporting requirements and thresholds that are jurisdiction specific.

Compliance with the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the “Act”) is mandatory pursuant to subsections 272(1) and 272.1(1) of the Act. Amendments to the fine scheme of the Act came into force on June 22, 2012. Subsections 272(2), (3) and (4) and 272.1(2), (3) and (4) of the Act set the penalties for persons who commit an offence under the Act. Offences include the offence of failing to comply with an obligation arising from the Act and the offence of providing false or misleading information. Penalties for offences can result, upon conviction (either summary conviction or indictment) of fines of not more than $12 million, imprisonment for a term of not more than three years, or both.

The current text of the Act, including the most recent amendments, is available on Justice Canada’s Web site: laws-lois.justice.gc.ca/eng/acts/C-15.31/.

The Act is enforced in accordance with the Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 available at www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=5082BFBE-1. Suspected violations under the Act can be reported to the Enforcement Branch by email at environmental.enforcement@ec.gc.ca.

An electronic copy of this notice is available at the following Internet addresses: www.ec.gc.ca/CEPAregistry/notices or www.ec.gc.ca/ges-ghg.

[44-1-o]

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of azo disperse dyes specified on the Domestic Substances List (paragraphs 68(b) and (c) and subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 72 of the 73 azo disperse dyes identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on certain azo disperse dyes pursuant to paragraphs 68(b) and (c) or section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that azo disperse dyes meet one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health (the ministers) propose to recommend to His Excellency the Governor in Council that azo disperse dyes be added to Schedule 1 to the Act;

And notice is furthermore given that the ministers have released a risk management scope document for the azo disperse dyes to initiate discussions with stakeholders on the development of a risk management approach.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).

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.

DAVID MORIN
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
VIRGINIA POTER
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment
AMANDA JANE PREECE
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Draft Screening Assessment of Certain Azo Disperse Dyes

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment on 73 azo disperse dyes. These substances constitute a subgroup of the Aromatic Azo and Benzidine-based Substance Grouping being assessed as part of the Substance Groupings Initiative of Canada’s Chemicals Management Plan (CMP) based on similar chemical structures and application. Substances in this grouping were identified as priorities for action as they met categorization criteria under subsection 73(1) of CEPA 1999 and/or were considered as priority substances under the CMP based on other human health concerns.

Assessments to determine whether 24 of these substances met one or more criteria under section 64 of CEPA 1999 were previously conducted under the Challenge Initiative of the CMP. As outlined in the Notice of Intent for the Aromatic Azo and Benzidine-based Substance Grouping, (see footnote 4) it was recognized by the Government of Canada that assessments and conclusions pertaining to some of the substances in the Substance Grouping may be subsequently updated as part of the current subgroup assessment. Specifically, significant new information has been identified that informs the ecological assessment of the Azo Disperse Dyes subgroup, and assessments for the above-noted 24 substances were updated in the context of the current subgroup assessment. Additionally, based on significant new information pertaining to human health, assessments for 13 of the 24 substances were updated in the context of the subgroup assessment.

The identities of the 73 azo disperse dyes, including those substances for which previous assessments are being updated, are presented in the following table.

Identity of 73 azo disperse dyes in the Aromatic Azo and Benzidine-based Substance Grouping
CAS RN (see reference *) Domestic Substances List name Colour Index name or acronym
2537-62-4 Acetamide, N-[2-[(2-bromo-6-cyano4-nitrophenyl)azo]-5-(diethylamino)phenyl]- N/A
3618-72-2 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-bromo-4, 6-dinitrophenyl)azo]-4-methoxyphenyl]- Disperse Blue 79:1
5261-31-4 (see reference a1) Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2, 6-dichloro-4-nitrophenyl)azo] phenyl]amino]- Disperse Orange 30
6232-56-0 (see reference a2) Ethanol, 2-[[4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]methylamino]- Disperse Orange 5
6250-23-3 (see reference a3) Phenol, 4-[[4-(phenylazo)phenyl]azo]- Disperse Yellow 23
6253-10-7 (see reference a4) Phenol, 4-[[4-(phenylazo)-1-naphthalenyl]azo]- Disperse Orange 13
6300-37-4 (see reference a5) Phenol, 2-methyl-4-[[4-(phenylazo)phenyl]azo]- Disperse Yellow 7
6465-02-7 Carbamic acid, [4-[[4-[(4-hydroxyphenyl)azo]-2-methylphenyl]azo]phenyl]-, methyl ester N/A
6657-00-7 Phenol, 4-[[2-methoxy-5-methyl-4-(phenylazo) phenyl]azo]- N/A
12239-34-8 (see reference a6) Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-bromo-4, 6-dinitrophenyl)azo]-4-ethoxyphenyl]- Disperse Blue 79
15958-27-7 Propanenitrile, 3-[[4-[(4-nitrophenyl)azo]phenyl][2-[[(phenylamino)carbonyl]oxy]ethyl]amino]- N/A
16421-40-2 (see reference a7) Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2[(2-chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]- ANAM (see reference b1)
16421-41-3 (see reference a8) Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]2-[(2,4-dinitrophenyl)azo]-4-methoxyphenyl]- N/A
16586-42-8 (see reference a9) Propanenitrile, 3-[ethyl[3-methyl-4-[(6-nitro2-benzothiazolyl)azo]phenyl]amino]- NBATP (see reference b2)
17464-91-4 (see reference a10) Ethanol, 2,2′-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bis- Disperse Brown 1:1
19745-44-9 Propanenitrile, 3-[4-[(5-nitro-2-thiazolyl)azo](2-phenylethyl)amino]- N/A
19800-42-1 (see reference a11) Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- Disperse Orange 29
21811-64-3 (see reference a12) Phenol, 4,4′-[1,4-phenylenebis(azo)]bis- Disperse Yellow 68
23355-64-8 (see reference a13) Ethanol, 2,2′-[[3-chloro-4-[(2,6-dichloro4-nitrophenyl)azo]phenyl]imino]bis- Disperse Brown 1
24610-00-2 Benzonitrile, 2-[[4-[(2-cyanoethyl)(2-phenylethyl)amino]phenyl]azo]-5-nitro- N/A
25150-28-1 Propanenitrile, 3-[[4-[(6,7-dichloro2-benzothiazolyl)azo]phenyl]ethylamino]- N/A
25176-89-0 (see reference a14) Propanenitrile, 3-[[4-[(5,6-dichloro2-benzothiazolyl)azo]phenyl]ethylamino]- DAPEP (see reference b3)
26021-20-5 Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-[(2-cyanoethyl) (2-hydroxyethyl)amino]-4-methoxyphenyl]- Disperse Blue 94
26850-12-4 (see reference a15) Propanamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-chloro4-nitrophenyl)azo]phenyl]- Disperse Red 167
27184-69-6 Phenol, 4,4′-[1,4-phenylenebis(azo)] bis[3-methyl- N/A
28824-41-1 Propanenitrile, 3-[[4-[(4,6-dibromo2-benzothiazolyl)azo]phenyl]ethylamino]- N/A
29765-00-2 (see reference a16) Benzamide, N-[5[bis[2-(acetyloxy)ethyl]amino]2-[(4-nitrophenyl)azo]phenyl]- BANAP (see reference b4)
31030-27-0 Benzenamine, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-(2-phenoxyethyl)- N/A
33979-43-0 Propanenitrile, 3-[[2-(acetyloxy)ethyl] [4-[(5,6-dichloro2-benzothiazolyl)azo]phenyl]amino]- N/A
41362-82-7 Propanenitrile, 3-[[4-[(5,6-dichloro2-benzothiazolyl)azo]phenyl]methylamino]- N/A
42357-98-2 1H-Benz[de]isoquinoline-1,3(2H)-dione, 6-hydroxy-5-[(2-methoxy-4-nitrophenyl)azo]-2-methyl- N/A
42358-36-1 1H-Benz[de]isoquinoline-1,3(2H)-dione, 2-ethyl-6-hydroxy-5-[(2-methoxy-4-nitrophenyl)azo]- N/A
42852-92-6 Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-4-methoxy-5-[(phenylmethyl)-2-propenylamino]phenyl]- N/A
51249-07-1 3-Pyridinecarbonitrile, 1-(2-ethylhexyl)-1, 2-dihydro-6-hydroxy-4-methyl-5-[(2-nitrophenyl)azo]-2-oxo- N/A
52697-38-8 (see reference a17) Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]- N/A
53950-33-7 (see reference †2) Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-[(2-cyanoethyl)amino]4-methoxyphenyl]- N/A
55252-53-4 Acetamide, N-[2-[(2-cyano-6-iodo-4-nitrophenyl)azo]-5-(diethylamino)phenyl]- N/A
55281-26-0 (see reference a18) Propanenitrile, 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]- Disperse Orange 61
55290-62-5 Benzenesulfonamide, 4-[(1-butyl-5-cyano-1, 6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl)azo]-N-(2-ethylhexyl)- N/A
55619-18-6 (see reference a19) Ethanol, 2,2′-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]imino]bis-, diacetate (ester) N/A
56532-53-7 Acetamide, N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(dipropylamino)phenyl]- N/A
58104-55-5 2-Naphthalenesulfonamide, 6-hydroxy-N(2-hydroxyethyl)-N-methyl-5-[[4-(phenylazo)phenyl]azo]- N/A
59709-38-5 (see reference a20) β-Alanine, N-[4-[(2-bromo-6-chloro4-nitrophenyl)azo]phenyl]-N-(3-methoxy3-oxopropyl)-, methyl ester ANMOM (see reference b5)
61799-13-1 3-Pyridinecarbonitrile, 5-[(2-cyano-4-nitrophenyl)azo]-2-[(2-hydroxyethyl)amino]4-methyl-6-[[3-(2-phenoxyethoxy)propyl]amino]- N/A
63133-84-6 1(2H)-Quinolineethanol, 6-[(2-chloro-4, 6-dinitrophenyl)azo]-3,4-dihydro-2,2,4,7-tetramethyl- N/A
63134-15-6 Acetamide, N-[5-(dipropylamino)2-[[5-(ethylthio)-1,3,4-thiadiazol2-yl]azo]phenyl]- Disperse Red 338
63833-78-3 3-Pyridinecarbonitrile, 5-[(2-cyano-4-nitrophenyl)azo]-6-[(2-hydroxyethyl)amino]4-methyl-2-[[3-(2-phenoxyethoxy)propyl]amino]- N/A
65122-05-6 Diazene, [(1,3-dihydro-1,1,3-trimethyl2H-inden-2-ylidene)methyl] (2-methoxyphenyl)- N/A
66693-26-3 Propanamide, N-[5-[bis[2-(2-cyanoethoxy)ethyl]amino]-2-[(2-chloro-4, 6-dinitrophenyl)azo]-4-methoxyphenyl]- Disperse Blue 125
67905-67-3 Propanenitrile, 3-[butyl[4-[(6-nitro2-benzothiazolyl)azo]phenyl]amino]- N/A
68214-63-1 3-Pyridinecarbonitrile, 5-[(3,4-dichlorophenyl)azo]-1,2-dihydro6-hydroxy-4-methyl-2-oxo-1-(phenylamino)- N/A
68214-66-4 Carbamic acid, [2-[(2-chloro-4-nitrophenyl)azo]-5-(diethylamino)phenyl]-, 2-ethoxyethyl ester N/A
68516-64-3 Propanenitrile, 3-[[2-(acetyloxy)ethyl] [4-[(2-chloro-4-nitrophenyl)azo]3-methylphenyl]amino]- N/A
68877-63-4 Acetamide, N-[2-[(2-bromo-4, 6-dinitrophenyl)azo]-5-[(2-cyanoethyl)2-propenylamino]-4-methoxyphenyl]- N/A
68992-01-8 3-Pyridinecarbonitrile, 1-(2-ethylhexyl)-1, 2-dihydro-6-hydroxy-5-[(4-methoxy2-nitrophenyl)azo]-4-methyl-2-oxo- N/A
69472-19-1 Propanenitrile, 3-[butyl[4-[(4-nitrophenyl)azo]phenyl]amino]- N/A
70210-08-1 2-Naphthalenesulfonamide, N-[2-(acetyloxy)ethyl]-6-hydroxy-N-methyl5-[[4-(phenylazo)phenyl]azo]- Disperse Red 151
70660-55-8 1-Naphthalenamine, 4-[(2-bromo-4, 6-dinitrophenyl)azo]-N-(3-methoxypropyl)- N/A
72828-63-8 Benzonitrile, 2-[[4-[[2-(acetyloxy)ethyl]butylamino]-2-methylphenyl]azo]-3-bromo-5-nitro- N/A
72828-64-9 1,3-Benzenedicarbonitrile, 2-[[4-[[2-(acetyloxy)ethyl]butylamino]-2-methylphenyl]azo]-5-nitro- Disperse Blue 287
72927-94-7 (see reference a21) Benzenamine, 4-[(2,6-dichloro-4-nitrophenyl)azo]-N-(4-nitrophenyl)- N/A
72968-82-2 (see reference a22) Methanesulfonamide, N-[2-[(2,6-dicyano4-methylphenyl)azo]5-(dipropylamino)phenyl]- DADM (see reference b6)
73003-64-2 2,4,10-Trioxa-7-azaundecan-11-oic acid, 7-[4-[(2,6-dichloro-4-nitrophenyl)azo]-3-methylphenyl]-3-oxo-, methyl ester N/A
73398-96-6 3-Pyridinecarbonitrile, 5-[(9,10-dihydro-9, 10-dioxo-1-anthracenyl)azo]-2,6-bis[(2-methoxyethyl)amino]-4-methyl- Disperse Brown 21
79542-46-4 Acetamide, N-[4-chloro-2-[2-(2-chloro4-nitrophenyl)azo]-5-[(2-hydroxy-3-phenoxypropyl)amino]phenyl]- Disperse Red 349
83249-47-2 Acetamide, N-[2-[(2-bromo-6-cyano-4-nitrophenyl)azo]-5-(dipropylamino)phenyl]- N/A
83249-49-4 Benzonitrile, 3-bromo-2-[[4-(diethylamino)2-methylphenyl]azo]-5-methyl- N/A
83249-53-0 Methanesulfonamide, N-[2-[(2-bromo6-cyano-4-methylphenyl)azo]-5-(diethylamino)phenyl]- N/A
83249-54-1 Methanesulfonamide, N-[2-[(2-bromo6-cyano-4-methylphenyl)azo]-5-(dipropylamino)phenyl]- N/A
90729-40-1 3-Pyridinecarbonitrile, 1-butyl5-[[4-(4-chlorobenzoyl)-2-nitrophenyl]azo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo- N/A
93805-00-6 (see reference a23) Phenol, 4-[[2-methoxy-4-[(2-methoxyphenyl)azo]-5-methylphenyl]azo]- N/A
106276-78-2 (see reference a24) Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[(4-aminophenyl)azo]-3-methylbenzenamine and sodium methoxide MATCB (see reference b7)
127126-02-7 Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(6, 7-dichloro-2-benzothiazolyl)azo]phenyl] amino]- N/A

Abbreviation: N/A, not available

  • Reference * The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
  • Reference †2 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference a1 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a2 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a3 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a4 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a5 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a6 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a7 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a8 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a9 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a10 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a11 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a12 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a13 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a14 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a15 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a16 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a17 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a18 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a19 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a20 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a21 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a22 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a23 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference a24 Previously concluded as not meeting section 64 of CEPA 1999.
  • Reference b1 The acronym that the substance was previously referred to under the Challenge initiative.
  • Reference b2 The acronym that the substance was previously referred to under the Challenge initiative.
  • Reference b3 The acronym that the substance was previously referred to under the Challenge initiative.
  • Reference b4 The acronym that the substance was previously referred to under the Challenge initiative.
  • Reference b5 The acronym that the substance was previously referred to under the Challenge initiative.
  • Reference b6 The acronym that the substance was previously referred to under the Challenge initiative.
  • Reference b7 The acronym that the substance was previously referred to under the Challenge initiative.

Azo disperse dyes are anthropogenically produced and are not expected to occur naturally in the environment. No manufacture of any substance above the 100 kg/year reporting threshold has been reported in response to any recent surveys under section 71 of CEPA 1999. Thirteen substances have been reported as having an import quantity above the 100 kg/year survey reporting threshold, with total quantities between 10 000 and 100 000 kg/year. No measured concentrations in the Canadian environment have been identified for any of these substances since 1987.

Environment

Due to similar physical and chemical properties, structural similarities and the expectation that azo disperse dyes will act in similar ways in the environment and will exert similar toxicities to organisms, they are considered in a general manner with respect to their environmental fate and potential to cause ecological harm; these considerations are not limited to the 73 Chemical Abstracts Service Registry Numbers (CAS RNs) identified in the table above. As specified in the Notice of Intent, assessment conclusions may also be relevant or apply to other related substances in the same class.

Based on the available experimental data, azo disperse dyes have low solubility in water (<1 mg/L) and moderate to high solubility in n-octanol (10–1 000 mg/L). They also possess low vapour pressures (<4.53 × 10−7 Pa), densities higher than that of water (1.19 × 103 – 1.55 × 103 kg/m3) and moderate to high octanol-water partition coefficients (log Kow ranging from 3.4 to 5.5).

Empirical data indicate that under aerobic conditions, azo disperse dyes are not expected to degrade rapidly in water, soil and sediment. If released to wastewater, these dyes are expected to be either caught by sludge filters or adsorbed during wastewater treatment, rather than staying in the water compartment. If released to water, it is anticipated that a greater percentage of these substances will find their way into sediment and undergo reductive degradation in anaerobic sediments. The bioavailability of these substances is expected to be low based on their low solubility in water and slow uptake due to their large cross-sectional diameters. Results from experimental studies suggest that the potential for these substances to bioaccumulate in pelagic organisms is low.

Azo disperse dyes are expected to have a common mode of action with respect to ecotoxicity, based on their physical and chemical properties and similar structural components. Due to the potential cleavage of the azo bonds, degradation products can be released containing the amine, aniline or phenolic functional groups resulting from biotransformation of the parent structure. It is thus considered that toxicity information for aquatic, sediment-dwelling and soil-dwelling organisms would apply to all azo disperse dyes.

The available ecotoxicity data for azo disperse dyes indicated highly variable effects on different taxa and between acute and chronic tests. Acute toxicity tests on fish demonstrated no effects near the known water solubility limits; however, available tests showed that early life stage fish and aquatic invertebrates were sensitive to azo disperse dyes. A predicted no-effect concentration (PNEC) in the aquatic environment was calculated to be 0.0025 mg/L, based on the lowest toxicity value from a chronic study on fish (fathead minnow) exposed to Disperse Yellow 7 (CAS RN 6300-37-4).

In preliminary soil toxicity studies on other azo substances, no effects were found at the concentration of 1 000 mg/kg soil (dry weight). Applying this value across the substances in this grouping, it is expected that azo disperse dyes are not harmful to soil-dwelling organisms.

To evaluate potential exposures to these substances in the aquatic environment, predicted environmental concentrations (PECs) were estimated, based on the available information. Thirty-eight mills at 21 sites that are likely to use these substances for textile dyeing have been identified. The wastewater treatment system effluent flow rate and the receiving river flow rate at each city were considered to calculate the PEC at each mill. PECs for 19 of 38 mills and 16 cities were found to be above the aquatic PNEC, indicating that estimated releases of azo disperse dyes to the environment may pose harm to aquatic organisms in some areas.

Based on the overall results of the ecological assessment, it is proposed to conclude that azo disperse dyes are 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.

Based on the lines of evidence in the ecological assessment, including aerobic persistence, high hazard in the aquatic environment at low concentrations and PECs exceeding the PNEC, it is therefore proposed to conclude that azo disperse dyes meet the criteria set out in paragraph 64(a) of CEPA 1999. This class decision is not limited to the 73 Chemical Abstracts Service Registry Numbers (CAS RNs) in this assessment and applies to other related substances with similar chemical structures and properties. However, it is proposed to conclude that the 73 azo disperse dyes do not meet the criteria under paragraph 64(b) of CEPA 1999, as they are 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.

Human health

With respect to human health risk assessment, the current screening assessment encompasses 62 azo disperse dyes, including 13 substances previously assessed for which significant new information has become available.

Carcinogenicity and genotoxicity are considered critical health effects of potential concern for aromatic azo and benzidine-based substances, due to potential azo bond cleavage and the release of aromatic amines. Therefore, the health effects of the azo disperse dyes were evaluated by examining their hazard potential (including their ability to undergo reductive cleavage and the hazard potential of the aromatic amines released), together with their potential for direct and prolonged exposure of the general population.

The potential for direct and prolonged general population exposure was identified for 11 azo disperse dyes (Disperse Blue 79:1, Disperse Orange 30, Disperse Blue 79, ANAM, Disperse Brown 1:1, Disperse Brown 1, Disperse Red 167, BANAP, CAS RN 52697-38-8, Disperse Orange 61 and CAS RN 63833-78-3). For these 11 azo disperse dyes, carcinogenicity was not identified as a critical health effect. For non-cancer effects, a critical effect level from a developmental toxicity study in rabbits administered Disperse Blue 79:1 based on decreased maternal body weight gain was identified. This critical effect level was used to characterize risk related to the 11 azo disperse dyes for which exposure of the general population of Canada is expected. Margins between upper-bounding estimates of exposure from direct and prolonged contact to textiles containing these dyes and the critical effect level were considered to be adequate to address uncertainties in the health effects and exposure databases.

For the remaining azo disperse dyes, available information did not identify the potential for direct and prolonged exposure of the general population of Canada. Therefore, the risk for the general population of Canada from exposure to these substances is expected to be low.

On the basis of the available data, it is proposed to conclude that 62 azo disperse dyes, including 13 substances previously assessed for which significant new information was available, 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. It is therefore proposed to conclude that 62 azo disperse dyes do not meet the criteria set out in paragraph 64(c) of CEPA 1999. In addition, there are no updates to the assessments and conclusions made with respect to paragraph 64(c) for 11 substances previously considered by the Government of Canada under the Challenge Initiative of the CMP.

Overall proposed conclusion

Based on the information available, it is proposed to conclude that azo disperse dyes meet one or more of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment, as well as the risk management scope document, for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Considerations for follow-up

Six azo disperse dyes are considered to have high human health hazard potential based on the potential genotoxicity and/or carcinogenicity of two aromatic amines, o-anisidine (CAS RN 90-04-0) and p-aminoazobenzene (CAS RN 60-09-3), that may be released following azo bond cleavage. o-Anisidine may be released from CAS RN 93805-00-6 and CAS RN 65122-05-6, and p-aminoazobenzene may be released from Disperse Yellow 23, Disperse Yellow 7, CAS RN 58104-55-5 and Disperse Red 151. Exposure of the general population of Canada is not currently expected for any of these six substances. However, there may be concerns if uses resulting in exposure were to increase in Canada, as these substances are recognized for their high human health hazard. To ensure consistency across this grouping, options on how best to monitor changes in the use profile of these substances, such as the monitoring of international activities or the surveillance of the Canadian marketplace, will be investigated as the assessments for all of the substances in the Aromatic Azo and Benzidine-based Substance Grouping are completed.

[44-1-o]

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of 22 azo solvent dyes specified on the Domestic Substances List (paragraphs 68(b) and (c) and subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 17 of the 22 azo solvent dyes identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on certain azo solvent dyes pursuant to paragraphs 68(b) and (c) or section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that 20 of the 22 azo solvent dyes do not meet any of the criteria set out in section 64 of the Act;

Whereas the Publication of final decision after screening assessment of a substance 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-(Solvent Red 23), CAS No. 85-86-9 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) was published in the Canada Gazette, Part Ⅰ, on September 10, 2011;

Whereas the final decision that Solvent Red 23 meets one or more of the criteria set out in section 64 of the Act remains unchanged;

Whereas the Minister of the Environment and the Minister of Health (the ministers) recommended to His Excellency the Governor in Council on October 15, 2011, that Solvent Red 23 be added to Schedule 1 to the Act;

And whereas it is proposed to conclude that Solvent Yellow 77 (CAS RN 2832-40-8) meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers intend to recommend to His Excellency the Governor in Council that Solvent Yellow 77 be added to Schedule 1 to the Act.

Notice therefore is hereby given that the ministers propose to take no further action on 20 azo solvent dyes at this time.

And notice is also hereby given that the ministers have released a risk management scope document for Solvent Yellow 77 to initiate discussions with stakeholders on the development of a risk management approach.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).

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.

DAVID MORIN
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
VIRGINIA POTER
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment
AMANDA JANE PREECE
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Draft Screening Assessment of Certain Azo Solvent Dyes

Pursuant to sections 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on 22 azo solvent dyes. These substances constitute a subgroup of the 358 Aromatic Azo and Benzidine-based Substance Grouping being assessed as part of the Substance Groupings Initiative of Canada’s Chemicals Management Plan (CMP). Substances in this grouping were identified as priorities for action as they met categorization criteria under subsection 73(1) of CEPA 1999 and/or were considered as priority substances under the CMP based on other human health concerns.

Assessments to determine whether five of the azo solvent dyes (Solvent Red 1, Solvent Red 3, Solvent Red 23, Solvent Yellow 18 and Solvent Orange 7) met one or more criteria under section 64 of CEPA 1999 were previously conducted under the Challenge Initiative of the CMP. Among them, one substance (Solvent Red 23) was concluded to meet one or more criteria as set out in section 64 of CEPA 1999. As outlined in the Notice of Intent for the Aromatic Azo and Benzidine-based Substance Grouping, (see footnote 5) it was recognized by the Government of Canada that assessments and conclusions pertaining to some of the substances in the grouping may be subsequently updated as part of the current subgroup assessment. Specifically, significant new information has been identified to inform the ecological assessment of the azo solvent dyes subgroup, and the assessments for the five substances have been updated accordingly. Similarly, significant new information pertaining to human health has been identified for three of the five substances (Solvent Red 1, Solvent Red 3 and Solvent Yellow 18), and the human health risk assessments for these three substances have been updated.

The identities of the 22 substances are presented in the following table.

Twenty-two azo solvent dyes in the Aromatic Azo and Benzidine-based Substance Grouping
CAS RN (see reference a25) Domestic Substances List name Colour Index name or common name
60-09-3 (see reference b8) Benzenamine, 4-(phenylazo)- Solvent Yellow 1 or p-Aminoazobenzene
60-11-7 (see reference b9) Benzenamine, N,N-dimethyl4-(phenylazo)- Solvent Yellow 2
85-83-6 (see reference b10) 2-Naphthalenol, 1-[[2-methyl4-[(2-methylphenyl)azo]phenyl]azo]- Solvent Red 24 or Sudan IV
85-86-9 (see reference c1) 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]- Solvent Red 23 or Sudan III
97-56-3 (see reference b11) Benzenamine, 2-methyl4-[(2-methylphenyl)azo]- Solvent Yellow 3
101-75-7 Benzenamine, N-phenyl-4-(phenylazo)- 4-Anilinoazobenzene
103-33-3 (see reference b12) Diazene, diphenyl- Azobenzene
495-54-5 1,3-Benzenediamine, 4-(phenylazo)- Solvent Orange 3
842-07-9 2-Naphthalenol, 1-(phenylazo)- Solvent Yellow 14 or Sudan I
1229-55-6 (see reference c2) 2-Naphthalenol, 1-[(2-methoxyphenyl)azo]- Solvent Red 1
2646-17-5 2-Naphthalenol, 1-[(2-methylphenyl)azo]- Solvent Orange 2 or Oil Orange SS
2653-64-7 2-Naphthalenol, 1-(1-naphthalenylazo)- Solvent Red 4
2832-40-8 Acetamide, N-[4-[(2-hydroxy5-methylphenyl)azo]phenyl]- Solvent Yellow 77
3118-97-6 (see reference c3) 2-Naphthalenol, 1-[(2,4-dimethylphenyl)azo]- Solvent Orange 7 or Sudan II
5290-62-0 1-Naphthalenol, 4-[(4-nitrophenyl)azo]- Magneson II
6368-72-5 2-Naphthalenamine, N-ethyl1-[[4-(phenylazo)phenyl]azo]- Solvent Red 19
6407-78-9 (see reference c4) 3H-Pyrazol-3-one, 4-[(2,4-dimethylphenyl)azo]2,4-dihydro-5-methyl-2-phenyl- Solvent Yellow 18
6535-42-8 (see reference c5) 1-Naphthalenol, 4-[(4-ethoxyphenyl)azo]- Solvent Red 3
21519-06-2 3H-Pyrazol-3-one, 2,4-dihydro2-(3-hydroxyphenyl)-5-methyl4-[[4-(phenylazo)phenyl]azo]- N/A
73507-36-5 (see reference d1) 2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-, compounds with N,N′-bis (mixed Ph and tolyl and xylyl)guanidine monohydrochloride- N/A
73528-78-6 3-Pyridinecarbonitrile, 5-[[4-[(2,6-dichloro-4-nitrophenyl)azo]2,5-dimethoxyphenyl]azo]2,6-bis[(2-methoxyethyl)amino]-4-methyl- N/A
85392-21-8 3-Pyridinecarbonitrile, 5-[[2-chloro4-(phenylazo)phenyl]azo]2,6-bis[(3-methoxypropyl)amino]4-methyl- N/A

Abbreviation: N/A, not available

  • Reference a25 The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
  • Reference b8 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered as a priority based on other human health concerns.
  • Reference b9 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered as a priority based on other human health concerns.
  • Reference b10 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered as a priority based on other human health concerns.
  • Reference b11 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered as a priority based on other human health concerns.
  • Reference b12 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered as a priority based on other human health concerns.
  • Reference c1 This substance was previously assessed under the Challenge Initiative of the CMP and conclusions were drawn about it.
  • Reference c2 This substance was previously assessed under the Challenge Initiative of the CMP and conclusions were drawn about it.
  • Reference c3 This substance was previously assessed under the Challenge Initiative of the CMP and conclusions were drawn about it.
  • Reference c4 This substance was previously assessed under the Challenge Initiative of the CMP and conclusions were drawn about it.
  • Reference c5 This substance was previously assessed under the Challenge Initiative of the CMP and conclusions were drawn about it.
  • Reference d1 This CAS RN is an UVCB (unknown or variable composition, complex reaction products, or biological materials).

Azo solvent dyes are anthropogenically produced and are not expected to occur naturally in the environment. Eight of the 22 substances have been found to be in commerce in Canada, which includes the import of consumer products containing these substances. Five of these substances have been reported to be imported into Canada above reporting thresholds. No measured concentrations in the Canadian environment have been identified for any of these substances.

Environment

Azo solvent dyes are generally hydrophobic substances that are sparingly soluble in water, with some monoazo substances in this subgroup having experimental water solubility slightly above 1 mg/L. Given the import and use of five azo solvent dyes in Canada above reporting thresholds, potential releases to the aquatic environment and to the terrestrial environment (via municipal wastewater sludge) have been estimated. When considering potential releases to water, sediment, and soil, and the physical and chemical properties of these substances, it is expected that the azo solvent dyes may remain in the water column up to their apparent water solubility limit, and may also ultimately partition to suspended solids, sediments or soil particles. Available experimental and modelled data regarding the abiotic and biotic degradation of the azo solvent dyes indicate that these substances are persistent in water, sediment and soil. In anaerobic environments (i.e. anoxic layers of sediments), there is the potential for these substances to degrade to aromatic amines as a result of cleavage of the azo bond under anaerobic or reducing conditions.

Although there are limited experimental data available, information (including modelled data) on the log octanol–water partition coefficients (Kow) and fish bioconcentration factors (BCFs) indicates that these substances are not likely to bioconcentrate or bioaccumulate in aquatic organisms. These results were substantiated with modelled data that considered metabolism.

All of the structurally related azo solvent dyes (with the exception of CAS RN 73507-36-5) are expected to have a common mode of action with respect to ecotoxicity, based on the reactivity of the amine, aniline, or phenolic functional groups. It was thus proposed to conclude that toxicity information for aquatic and sediment- and soil-dwelling organisms would apply to all of these 21 structurally related substances. Toxicity information for these substances indicates that they are hazardous to aquatic organisms at low concentrations. Sediment-dwelling organisms may also be adversely affected, although the available toxicological data are preliminary. Toxicity information for CAS RN 73507-36-5 indicates that it would not be expected to be harmful to aquatic organisms at low concentrations.

Aquatic exposure analyses were focused on scenarios representing potential major environmental releases due to industrial activities involving azo solvent dyes that may result in high levels of exposure to aquatic organisms. Predicted environmental concentrations (PECs) were calculated for the aquatic environment for those substances identified in industrial formulation activities. The PECs were found to exceed the predicted no-effect concentration (PNEC) for water at one site where Solvent Yellow 77 is used.

Considering all available lines of evidence presented in this draft screening assessment, there is a risk of harm to organisms from Solvent Yellow 77 (CAS RN 2832-40-8). It is therefore proposed to conclude that Solvent Yellow 77 meets the criteria under paragraph 64(a) of CEPA 1999, 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, there is a low risk of harm to the broader integrity of the environment from Solvent Yellow 77. It is therefore proposed to conclude that Solvent Yellow 77 does not meet the criteria under paragraph 64(b) of CEPA 1999, 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.

Considering all available lines of evidence presented in this draft screening assessment, there is low risk of harm to organisms and the broader integrity of the environment from the remaining 21 azo solvent dyes. It is therefore proposed to conclude that these 21 substances in this screening assessment do not meet the criteria under paragraph 64(a) or (b) of CEPA 1999, 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.

As part of a separate ongoing screening assessment of azo disperse dyes also conducted under the Substance Groupings Initiative, it has been proposed to conclude that azo disperse dyes meet the criteria under paragraph 64(a) of CEPA 1999. Due to similarity in chemical structures and properties, some azo solvent dyes may fall within the scope of the azo disperse dyes class of substances for which it has been proposed to conclude that they have the potential to cause ecological harm in Canada.

Human health

With respect to human health risk assessment, the current screening assessment encompasses 20 azo solvent dyes, including three (Solvent Red 1, Solvent Red 3 and Solvent Yellow 18) that were previously assessed under the Challenge Initiative and about which conclusions were drawn. These three substances must now be reassessed, as significant new information relevant to the effects on human health from exposure to the substances has become available. The 20 azo solvent dyes were evaluated in three health subsets: “Azobenzene and Its Derivatives,” “Sudan Dyes” and “Miscellaneous Substances.” Solvent Orange 7 and Solvent Red 23, which were also previously assessed under the Challenge Initiative and conclusions were drawn about them, were not evaluated in this report, as no significant new information was identified. Structurally, Solvent Orange 7 and Solvent Red 23 belong to the Sudan Dyes health subset. Information on the two substances is considered only to support the data read-across approach among the Sudan Dyes.

Based on the empirical data identified, the critical health effects associated with exposure to Azobenzene and Its Derivatives (i.e. Azobenzene, p-Aminoazobenzene, Solvent Yellow 2, Solvent Orange 3, Solvent Yellow 3 and Solvent Yellow 77) are considered to be carcinogenicity and genotoxicity. In addition, Azobenzene, p-Aminoazobenzene, Solvent Yellow 2 and Solvent Yellow 77 are considered to have haematological effects. For the Sudan Dyes (i.e. Sudan I, Oil Orange SS, Solvent Red 1 and Sudan IV), based on the empirical data identified and data read-across, these substances are considered to have carcinogenic and genotoxic potential as well as potential to cause haematological effects. For the Miscellaneous Substances (i.e. Solvent Red 3, Solvent Yellow 18, Solvent Red 19, 4-Anilinoazobenzene, Solvent Red 4, Magneson II, and CAS RN 21519-06-2, CAS RN 73507-36-5, CAS RN 73528-78-6 and CAS RN 85392-21-8), only limited empirical data were identified; hence, their critical health effects cannot be conclusively determined.

Exposure of the general population in Canada to the 20 azo solvent dyes from environmental media is either not expected or considered negligible. Seven solvent dyes (Solvent Orange 3, Solvent Yellow 77, Sudan I, Solvent Red 1, Sudan IV, Solvent Red 3 and Solvent Yellow 18) were indicated to be present in certain consumer products (textiles, leathers, writing ink, paper products, cosmetics and food packaging material) in the Canadian marketplace. Margins between the upper-bounding estimates of exposure to Solvent Orange 3, Solvent Yellow 77, Sudan I, Solvent Red 1 and Solvent Red 3 from use of consumer products containing these substances and the critical health effect levels were considered adequate to address uncertainties in the health effects and exposure databases. Based on limited data for Solvent Yellow 18 and for its structural analogue, Solvent Yellow 18 was not identified as having high hazard potential and, accordingly, risk to the general population of Canada from exposure to Solvent Yellow 18 is considered low. Additionally, human health risk from exposure to Sudan IV, which may be present in food packaging material, is not expected.

For the rest of the 13 azo solvent dyes, available information did not identify potential for exposure for the general population of Canada. Therefore, risk for the general population of Canada of exposure to these substances is not expected.

On the basis of the available data, it is proposed to conclude that the 20 azo solvent dyes 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. It is proposed that the 20 azo solvent dyes do not meet the criteria set out in paragraph 64(c) of CEPA 1999. Accordingly, there are no changes to the conclusions previously made on Solvent Red 1, Solvent Red 3 and Solvent Yellow 18 with respect to the criteria set out in paragraph 64(c) of CEPA 1999.

Overall proposed conclusion

Based on the information available, it is proposed to conclude that Solvent Yellow 77 (CAS RN 2832-40-8) meets one or more criteria set out under section 64 of CEPA 1999.

It is also proposed to conclude that the substances listed in the table below do not meet any of the criteria set out in section 64 of CEPA 1999.

Substances that do not meet criteria set out under paragraphs 64(a), 64(b) and 64(c) of CEPA 1999
CAS RN Colour Index name or common name
60-09-3 Solvent Yellow 1 or p-Aminoazobenzene
60-11-7 Solvent Yellow 2
85-83-6 Solvent Red 24 or Sudan IV
97-56-3 Solvent Yellow 3
101-75-7 4-Anilinoazobenzene
103-33-3 Azobenzene
495-54-5 Solvent Orange 3
842-07-9 Solvent Yellow 14 or Sudan I
1229-55-6 Solvent Red 1
2646-17-5 Solvent Orange 2 or Oil Orange SS
2653-64-7 Solvent Red 4
3118-97-6 Solvent Orange 7 or Sudan II
5290-62-0 Magneson II
6368-72-5 Solvent Red 19
6407-78-9 Solvent Yellow 18
6535-42-8 Solvent Red 3
21519-06-2 N/A
73507-36-5 N/A
73528-78-6 N/A
85392-21-8 N/A

Abbreviations: CAS RN, Chemical Abstracts Service Registry Number; N/A, not available

The draft Screening Assessment for the 22 azo solvent dyes, as well as the risk management scope document for Solvent Yellow 77, is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Considerations for follow-up

Although currently no or limited risk to the environment has been identified for the 21 azo solvent dyes addressed in this assessment (not including CAS RN 73507-36-5), toxicity data for these substances indicate hazards to aquatic organisms at low concentrations. Similarly, although there is currently no or limited risk to the general population of Canada, 5 azo solvent dyes, p-aminoazobenzene, Solvent Yellow 2, Solvent Yellow 3, Oil Orange SS and Solvent Red 1, are recognized for their high human health hazard. There may be concerns for these substances if uses resulting in exposure were to increase in Canada. To ensure consistency across this grouping, options on how best to monitor changes in the use profile of these substances, such as monitoring of international activities or surveillance of the Canadian marketplace, will be investigated as the assessments for all of the substances in the Aromatic Azo and Benzidine-based Substance Grouping are completed.

[44-1-o]

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of 33 monoazo pigments specified on the Domestic Substances List (paragraphs 68(b) and (c) and subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 25 of the 33 monoazo pigments identified in the annex below are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on certain monoazo pigments pursuant to paragraphs 68(b) and (c) or section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that 31 of the 33 monoazo pigments do not meet any of the criteria set out in section 64 of the Act;

Whereas the Publication of final decision on the screening assessment of a substance — 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- (Pigment Red 3), CAS No. 2425-85-6 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999) appeared in the Canada Gazette, Part Ⅰ, on March 7, 2009;

Whereas the final decision that Pigment Red 3 meets one or more of the criteria set out in section 64 of the Act remains unchanged;

Whereas Pigment Red 3 was added to Schedule 1 to the Canadian Environmental Protection Act, 1999 on February 16, 2011, by His Excellency the Governor in Council on the recommendation of the Minister of the Environment and the Minister of Health (the ministers);

And whereas it is proposed to conclude that Pigment Red 4 (CAS RN 2814-77-9) meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers intend to recommend to His Excellency the Governor in Council that Pigment Red 4 be added to Schedule 1 to the Act.

Notice therefore is hereby given that the ministers propose to take no further action on 31 monoazo pigments at this time.

And notice is also hereby given that the ministers have released a risk management scope document for Pigment Red 4 to initiate discussions with stakeholders on the development of a risk management approach.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). All comments must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).

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.

DAVID MORIN
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
VIRGINIA POTER
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment
AMANDA JANE PREECE
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the Draft Screening Assessment of Certain Monoazo Pigments

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the ministers of the Environment and of Health have conducted a screening assessment of 33 monoazo pigments. These substances constitute a subgroup of the Aromatic Azo and Benzidine-based Substance Grouping being assessed as part of the Substance Groupings Initiative of Canada’s Chemicals Management Plan (CMP) based on similar chemical structures and application. Substances in this Grouping were identified as priorities for action as they met categorization criteria under subsection 73(1) of CEPA 1999 and/or were considered as priority substances under the CMP based on other human health concerns.

Assessments to determine whether 11 of the monoazo pigments (indicated with the letter “c” in the table) met one or more criteria under section 64 of CEPA 1999 were previously conducted under the Challenge Initiative of the CMP. Among them, one substance (Pigment Red 3) was concluded to meet one or more of the criteria set out in section 64 of CEPA 1999. As outlined in the Notice of Intent for the Aromatic Azo and Benzidine-based Substance Grouping, (see footnote 6) it was recognized by the Government of Canada that assessments and conclusions pertaining to some of the substances in the grouping may be subsequently updated as part of the current subgroup assessment. Specifically, significant new information pertaining to human health has been identified for 10 of the 11 substances (except Pigment Red 3) and the human health risk assessments for these 3 substances have been updated. The identities of the 33 substances are presented in the following table.

Thirty-three monoazo pigments in the Aromatic Azo and Benzidine-based Substance Grouping
CAS RN (see reference a26) Domestic Substances List name Colour Index name (Colour Index number) Chemical acronym
1103-38-4 1-Naphthalenesulfonic acid, 2-[(2-hydroxy-1-naphthalenyl)azo]-, barium salt (2:1) Pigment Red 49:1 (C.I. 15630:1) PR49:1
2425-85-6 (see reference c6) 2-Naphthalenol, 1-[(4-methyl2-nitrophenyl)azo]- Pigment Red 3 (C.I. 12120) PR3
2512-29-0 (see reference b13) Butanamide, 2-[(4-methyl2-nitrophenyl)azo]-3-oxo-N-phenyl- Pigment Yellow 1 (C.I. 11680) PY1
2786-76-7 2-Naphthalenecarboxamide, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxy- Pigment Red 170 (C.I. 12475) PR170
2814-77-9 (see reference c7) 2-Naphthalenol, 1-[(2-chloro4-nitrophenyl)azo]- Pigment Red 4 (C.I. 12085) PR4
3468-63-1 (see reference c8) 2-Naphthalenol, 1-[(2,4-dinitrophenyl)azo]- Pigment Orange 5 (C.I. 12075) PO5
5160-02-1 Benzenesulfonic acid, 5-chloro2-[(2-hydroxy-1-naphthalenyl)azo]-4-methyl-, barium salt (2:1) Pigment Red 53:1 (C.I. 15585:1) PR53:1
6372-81-2 Benzoic acid, 2-[(2-hydroxy1-naphthalenyl)azo]-, barium salt (2:1) Pigment Red 50:1 (C.I. 15500:1) PR50:1
6407-74-5 (see reference c9) 3H-Pyrazol-3-one, 4-[(2-chlorophenyl)azo]2,4-dihydro-5-methyl-2-phenyl- Pigment Yellow 60 (C.I. 12705) PY60
6410-09-9 (see reference c10) 2-Naphthalenol, 1-[(2-nitrophenyl)azo]- Pigment Orange 2 (C.I. 12060) PO2
6410-13-5 (see reference c11) 2-Naphthalenol, 1-[(4-chloro2-nitrophenyl)azo]- Pigment Red 6 (C.I. 12090) PR6
6410-41-9 (see reference c12) 2-Naphthalenecarboxamide, N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulfonyl]2-methoxyphenyl]azo]-3-hydroxy- Pigment Red 5 (C.I. 12490) PR5
6417-83-0 (see reference b14) 2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(1-sulfo2-naphthalenyl)azo]-, calcium salt (1:1) Pigment Red 63:1 (C.I. 15880:1) PR63:1
6486-23-3 (see reference b15) Butanamide, 2-[(4-chloro2-nitrophenyl)azo]-N(2-chlorophenyl)-3-oxo- Pigment Yellow 3 (C.I. 11710) PY3
6535-46-2 (see reference b16) 2-Naphthalenecarboxamide, 3-hydroxy-N-(2-methylphenyl)4-[(2,4,5-trichlorophenyl)azo]- Pigment Red 112 (C.I. 12370) PR112
7023-61-2 (see reference b17) 2-Naphthalenecarboxylic acid, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-, calcium salt (1:1) Pigment Red 48:2 (C.I. 15865:2) PR48:2
12236-62-3 (see reference b18) Butanamide, 2-[(4-chloro2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo- Pigment Orange 36 (C.I. 11780) PO36
12236-64-5 (see reference c13) 2-Naphthalenecarboxamide, N-[4-(acetylamino)phenyl]4-[[5-(aminocarbonyl)2-chlorophenyl]azo]-3-hydroxy- Pigment Orange 38 (C.I. 12367) PO38
12238-31-2 Pigment Red 52:2 Pigment Red 52:2 (C.I. 15860:2) PR52:2
13515-40-7 (see reference b19) Butanamide, 2-[(4-chloro2-nitrophenyl)azo]N-(2-methoxyphenyl)-3-oxo- Pigment Yellow 73 (C.I. 11738) PY73
13824-00-5 2-Naphthalenecarboxamide, 3-hydroxy-N-(4-methoxyphenyl)4-[(4-methylphenyl)azo]- Not available NAPMPA
16403-84-2 2-Naphthalenecarboxamide, 4-[[5-(aminocarbonyl)2-methylphenyl]azo]3-hydroxy-N-phenyl- Pigment Red 268 (C.I. 12316) PR268
17852-99-2 (see reference b20) 2-Naphthalenecarboxylic acid, 4-[(4-chloro-5-methyl2-sulfophenyl)azo]-3-hydroxy-, calcium salt (1:1) Pigment Red 52:1 (C.I. 15860:1) PR52:1
17947-32-9 2-Naphthalenecarboxamide, 3-hydroxy-N-(4-methoxyphenyl)4-(phenylazo)- Not available NAPPA
36968-27-1 2-Naphthalenecarboxamide, 4-[[4-(aminocarbonyl)phenyl]azo]3-hydroxy-N-(2-methoxyphenyl)- Pigment Red 266 (C.I. 12474) PR266
43035-18-3 (see reference c14) Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]1-naphthalenyl]azo]4-methylbenzoyl]amino]-, calcium salt (2:1) Pigment Red 247 (C.I. 15915) PR247
49744-28-7 2-Naphthalenol, 1-[(4-methoxy2-nitrophenyl)azo]- Not available NONPA
59487-23-9 (see reference c15) 2-Naphthalenecarboxamide, 4-[[5-[[[4-(aminocarbonyl)phenyl]amino] carbonyl]-2-methoxyphenyl]azo]N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxy- Pigment Red 187 (C.I. 12486) PR187
71832-83-2 2-Naphthalenecarboxylic acid, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-, magnesium salt (1:1) Pigment Red 48:5 (C.I. 15865:5) PR 48:5
74336-60-0 (see reference c16) 9,10-Anthracenedione, 1-[(5,7-dichloro-1,9-dihydro-2-methyl9-oxopyrazolo[5,1-b]quinazolin3-yl)azo]- Pigment Red 251 (C.I. 12925) PR251
83249-60-9 1-Naphthalenesulfonic acid, 2-[(2-hydroxy-6-sulfo1-naphthalenyl)azo]-, calcium salt (1:1) Not available NSNAC
85005-63-6 2-Naphthalenecarboxamide, 4-[(2,4-dinitrophenyl)azo]3-hydroxy-N-phenyl- Not available NANPAP
94199-57-2 2-Naphthalenecarboxamide, N-(2-ethoxyphenyl)-3-hydroxy4-[(2-nitrophenyl)azo]- Not available NAPNPA
  • Reference a26 The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
  • Reference b13 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b14 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b15 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b16 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b17 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b18 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b19 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference b20 This substance was not identified under subsection 73(1) of CEPA 1999 but was included in this assessment as it was considered a priority based on other human health concerns.
  • Reference c6 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c7 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c8 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c9 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c10 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c11 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c12 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c13 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c14 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c15 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.
  • Reference c16 This substance was previously assessed under the Challenge Initiative of the CMP, and conclusions were drawn about it.

Monoazo pigments are anthropogenically produced, and are not expected to be naturally occurring in the environment. Twenty-two of the thirty-three substances have been found to be in commerce in Canada, through either manufacturing of the substances or industrial activities requiring import of the substances above the reporting threshold of 100 kg/year. Some of the substances are also present in consumer products. No measured concentrations in the Canadian environment have been identified for any of these substances.

Environment

Monoazo pigments exist principally as particles in the sub- or low-micron range, and the pigment powder is typically composed of primary particles (i.e. the crystal lattice of a pigment), aggregates, and agglomerates. These 33 monoazo pigments have very low solubility in water (sub- to low-microgram per litre) and low solubility in octanol (below 20 mg/L); because of this, it is proposed that a quotient logarithm of the molar solute concentrations in octanol and water would reasonably represent the octanol–water partition coefficient for these pigments. Physical-chemical properties and the particulate nature of these substances suggest that soil and sediments are expected to be the two major environmental media of concern for monoazo pigments.

Experimental data indicate that under aerobic conditions, monoazo pigments are expected to be persistent in water, soil, and sediments. Bioavailability of monoazo pigments is expected to be low based on particulate character of these substances and low solubility in water. As a result, a potential to bioaccumulate in pelagic organisms is expected to be low, which is confirmed by the results of bioconcentration studies.

Due to limited bioavailability of monoazo pigments, in chronic soil toxicity studies, no effects were found at the concentration of 1 000 mg/kg soil (dry weight). These pigments also showed “no effect at saturation” in acute and chronic aquatic ecotoxicological studies where solvents were not used. The results of these studies allowed for making a proposed conclusion that monoazo pigments are not expected to be harmful to aquatic and soil-dwelling organisms at low (environmentally relevant) concentrations.

To evaluate potential exposures to monoazo pigments in the environment, environmental concentrations (PECs) were estimated; the industrial release scenario was chosen to evaluate the potential exposure to these substances. Predicted no-effect concentrations (PNECs) for water and soil were calculated based on the experimental critical toxicity values. Calculated risk quotients (PEC/PNEC) were lower than one, indicating that harm to organisms in water and soil is not expected.

Based on the overall results of ecological assessment, it is proposed to conclude that none of the 33 monoazo pigments considered in this assessment are 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 therefore proposed to conclude that all 33 monoazo pigments do not meet the criteria under paragraph 64(a) or (b) of CEPA 1999.

Human health

With respect to human health, the current screening assessment encompasses 32 substances in the monoazo pigments subgroup, including those substances previously assessed for which significant new information has become available except Pigment Red 3. Pigment Red 3 (a β- pigment) is considered only for read-across purposes to inform the human health effects assessment. In addition, the current assessment focuses on substances with identified sources of exposure for the general population.

The substances in this subgroup were evaluated in each of the subsets where structural similarity was recognized; β-naphthol pigments (PO2, PO5, PR4, PR6 and NONPA), β-naphthol pigment lakes (PR49:1, PR50:1 and PR53:1), BONA pigment lakes (PR48:2, PR48:5, PR52:1, PR52:2 and PR63:1), monoazo yellow pigments (PY1, PY3 and PY73), naphthol AS pigments (NANPAP, NAPMPA, NAPNPA, NAPPA, PO38, PR5, PR112, PR170, PR187, PR266 and PR268). The remaining five substances (NSNAC, PO36, PR247:1, PR251 and PY60) were evaluated as individual substances.

A range of data availability was identified across subsets. While a number of health effects studies were identified for the β-naphthol pigment subset, β-naphthol pigment lake subset and BONA pigment lake subset, limited health effects studies were identified for monoazo yellow pigment subset and naphthol AS pigment subset. No studies were identified for the other individual monoazo pigments in this assessment. Accordingly, read-across approaches were applied to characterize health effects of the monoazo pigments in this assessment as appropriate.

The β-naphthol pigments and β-naphthol pigment lakes exhibited similar toxicity in repeated-dose animal studies with target organs and systems including the hematopoetic system, liver and kidneys. While the β-naphthol pigments demonstrated mutagenic potential, the β-naphthol pigment lakes were predominantly negative in genotoxicity assays. Evidence for carcinogenicity was observed for both the β-naphthol pigment (liver tumours) and the β-naphthol pigment lake (liver and spleen tumours) subsets. In repeated-dose animal studies, the kidney was identified as the primary target organ for the BONA pigment lakes while these substances did not generally show the same hemolysis and liver toxicity observed for the β-naphthol pigments and β-naphthol pigment lakes. The BONA pigment lakes were generally negative in genotoxicity assays and, based on results from studies with the analogue PR57:1 did not exhibit carcinogenic potential. The available short-term toxicity data indicate a low hazard potential for the monoazo yellow pigment and naphthol AS pigment subsets.

Exposure to the 32 monoazo pigments via environmental media for the general population of Canada is not expected. The presence of the following 19 monoazo pigments in certain consumer products (e.g. face paint, finger paint, face mask, lipstick, and certain licensed natural health products) was identified in the Canadian market and the exposure to these substances for the general population of Canada has been characterized: NONPA, PO5, PO36, PO38, PR4, PR5, PR48:2, PR49:1, PR52:1, PR52:2, PR53:1, PR63:1, PR112, PR170, PR187, PR266, PY1, PY3 and PY73. While limited use was identified for 2 additional monoazo pigments (PR247:1 and PR268), exposure for the general population of Canada is considered negligible for these uses. The remaining 11 monoazo pigments (NANPAP, NAPMPA, NAPNPA, NAPPA, NSNAC, PO2, PR6, PR48:5, PR50:1, PR251 and PY60) were not identified in consumer products in the Canadian marketplace; therefore, exposure to these substances is not expected.

On the basis of the potential inadequacy of the margins between estimated oral exposures to PR4 in licensed natural health products and lipstick and the critical effect level for carcinogenicity (liver tumours), it is proposed to conclude that PR4 is potentially 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. It is therefore proposed to conclude that PR4 meets the criteria set out in paragraph 64(c) of CEPA 1999.

Based upon comparison between the upper-bounding estimates of short-term and chronic exposures from specifically identified consumer products and critical effect levels from animal studies, it is proposed to conclude that the following 18 monoazo pigments 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: NONPA, PO5, PO36, PO38, PR5, PR48:2, PR49:1, PR52:1, PR52:2, PR53:1, PR63:1, PR112, PR170, PR187, PR266, PY1, PY3 and PY73. For the remaining 13 substances (NANPAP, NAPMPA, NAPNPA, NAPPA, NSNAC, PO2, PR6, PR48:5, PR50:1, PR247:1, PR251, PR268 and PY60), available information did not identify potential for exposure of the general population of Canada. It is therefore proposed to conclude that the above-mentioned 31 substances do not meet the criteria set out in paragraph 64(c) of CEPA 1999.

Overall proposed conclusion

Based on the information available, it proposed to conclude that Pigment Red 4 (CAS RN 2814-77-9) meets one or more of the criteria set out in section 64 of CEPA 1999. However, it is also proposed to conclude that the substances listed in the following table do not meet any of the criteria set out in section 64 of CEPA 1999.

Substances that do not meet the criteria set out under paragraphs 64(a), 64(b) and 64(c) of CEPA 1999
CAS RN Chemical acronym
1103-38-4 PR49:1
2512-29-0 PY1
2786-76-7 PR170
3468-63-1 PO5
5160-02-1 PR53:1
6372-81-2 PR50:1
6407-74-5 PY60
6410-09-9 PO2
6410-13-5 PR6
6410-41-9 PR5
6417-83-0 PR63:1
6486-23-3 PY3
6535-46-2 PY112
7023-61-2 PR48:2
12236-62-3 PO36
12236-64-5 PO38
12238-31-2 PR52:2
13515-40-7 PY73
13824-00-5 NAPMPA
16403-84-2 PR268
17852-99-2 PR52:1
17947-32-9 NAPPA
36968-27-1 PR266
43035-18-3 PR247:1
49744-28-7 NONPA
59487-23-9 PR187
71832-83-2 PR48:5
74336-60-0 PR251
83249-60-9 NSNAC
85005-63-6 NANPAP
94199-57-2 NAPNPA

Abbreviation: CAS RN, Chemical Abstracts Service Registry Number

The draft Screening Assessment for the 33 monoazo pigments, as well as the risk management scope document for Pigment Red 4 are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Considerations for follow-up

Four β-naphthol pigments (NONPA, PO2, PO5 and PR6) are considered to have high human health hazard potential. Exposure of the general population of Canada is not currently expected for any of these four substances. However, there may be concerns if uses resulting in exposure were to increase in Canada. To ensure consistency across this grouping, options on how best to monitor changes in the use profile of these substances, such as monitoring of international activities or surveillance of the Canadian marketplace, will be investigated as the assessments for all of the substances in the Aromatic Azo and Benzidine-based Substance Grouping are completed.

[44-1-o]

DEPARTMENT OF HUMAN RESOURCES AND SKILLS DEVELOPMENT

EMPLOYMENT INSURANCE ACT

Resolution

Pursuant to section 66.5 of the Employment Insurance Act, notice is hereby given that the employment insurance premium rate for the year 2014 is $1.88 per $100 of insurable earnings.

Pursuant to subsections 76.07(2) and 76.35(2) of the Employment Insurance Regulations, notice is hereby given that the employment insurance premium reduction rate for the year 2014 for residents of Quebec covered under the Quebec Parental Insurance Plan is $0.35. Therefore, the employment insurance premium rate for residents of Quebec is $1.53 per $100 of insurable earnings.

THE HON. JASON KENNEY, P.C., M.P.
Minister of Human Resources and
Skills Development styled Minister of
Employment and Social Development

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DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person of the Saanich Police as a fingerprint examiner:

William John Dodds

Ottawa, October 16, 2013

KATHY THOMPSON
Assistant Deputy Minister
Law Enforcement and Policing Branch

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DEPARTMENT OF TRANSPORT

CANADA MARINE ACT

Thunder Bay Port Authority — Supplementary letters patent

BY THE MINISTER OF TRANSPORT

WHEREAS letters patent were issued by the Minister of Transport (“Minister”) for the Thunder Bay Port Authority (“Authority”), under the authority of the Canada Marine Act (“Act”), effective July 1, 1999;

WHEREAS Schedule C of the letters patent sets out the real property, other than federal real property, held or occupied by the Authority;

WHEREAS, pursuant to and subject to the terms and conditions of a Lease Agreement and Option Agreement between the Authority and Reimer Express Lines Ltd., both dated July 8, 2001, and assigned to Noma Brokerage Ltd. pursuant to a Consent Assignment for Agreement dated May 25, 2010, Noma Brokerage Ltd. has the option to purchase a three-acre parcel of land, forming part of the real property set out in item 2 of Schedule C of the letters patent, and now bearing the property identification number 62264-0447 (LT) (“Real Property”), subject to the issuance of supplementary letters patent;

WHEREAS Noma Brokerage Ltd. wishes to exercise their option to purchase the Real Property;

WHEREAS, pursuant to subsection 46(2) of the Act, the Authority wishes to dispose of the Real Property in favour of Noma Brokerage Ltd.;

WHEREAS the board of directors of the Authority has requested that the Minister issue supplementary letters patent to remove reference to the Real Property from Schedule C of the letters patent;

AND WHEREAS the Minister is satisfied that the amendment to the letters patent of the Authority is consistent with the Act,

NOW THEREFORE, pursuant to subsection 9(1) of the Act, the letters patent are amended as follows:

1. Item 2 of Schedule C of the letters patent is replaced by the following:

2. Parts of Parcel 16184 Thunder Bay Freehold being part of the Southeast Quarter of Section 52 and part of the Original Road Allowance in front of the Northeast Quarter of Section 52, formerly in the Township of McIntyre, now in the City of Thunder Bay, District of Thunder Bay, Province of Ontario, Parts of Lots 7, 8, 9 and 10 and part of Bay Avenue as stopped up and closed by Bill PR-39 of the City of Port Arthur, Registered Plan 1499 and that part of the South Half of the Northeast Quarter of Section 52 shown on said plan 1499 as 4 unnumbered lots lying east of Lot 10 on said plan designated as Parts 2, 3, 5 and 6 on Reference Plan 55R-9336.

EXCEPTING THEREFROM:

  • (a) Lot 5, Plan 55M-607, subject to an easement in favour of the Thunder Bay Hydro Electricity Distribution Inc. over part 5m 55R-12184, Thunder Bay being PN 62264-0448.
  • (b) Lot 4, Plan 55M-607, subject to easement in favour of the Corporation of the City of Thunder Bay over Part 4, 55R12184 as in F139546; subject to easement in favour of the Thunder Bay Hydro Electricity Distribution Inc. over Part 4, 55R12184 as in F139547; Thunder Bay (PIN 62264-0447 (LT)).

2. These supplementary letters patent take effect on the date of registration in the Thunder Bay Land Title Office of the documents evidencing the transfer of the Real Property from the Authority to Noma Brokerage Ltd.

ISSUED under my hand this 17th day of October, 2013.

___________________________________
Lisa Raitt, P.C., M.P.
Minister of Transport

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