Publication after screening assessment of a substance — 2-Propenamide (acrylamide), CAS No. 79-06-1 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas acrylamide is a substance 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 Report conducted on acrylamide pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that acrylamide meets 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 propose to recommend to Her Excellency the Governor in Council that acrylamide be added to Schedule 1 to the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance 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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Propenamide

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of 2-Propenamide (acrylamide), Chemical Abstracts Service Registry Number 79-06-1. The substance acrylamide was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. Acrylamide was identified as a high priority because it was considered to pose the greatest potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of carcinogenicity, genotoxicity and reproductive toxicity. The substance did not meet the ecological categorization criteria for persistence or bioaccumulation potential, but did meet the criteria for inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of acrylamide relates primarily to human health risks.

According to information reported under section 71 of CEPA 1999, between 1 and 10 million kg of acrylamide were imported into Canada in 2006. Based upon information presented in the available scientific and technical literature, the majority of acrylamide is used in the manufacture of various polymers, which in turn are used as binding, thickening, or flocculating agents in grout, cement, sewage/waste water treatment, pesticide formulations, cosmetics, sugar manufacturing, soil erosion prevention, ore processing, food packaging, plastic products and in molecular biology laboratory applications. In Canada, polyacrylamide is used as a coagulant and flocculant for the clarification of drinking water; it is also used in potting soils and as a non-medicinal ingredient in natural health products.

The greatest source of exposure of the general population to acrylamide is from its formation from naturally occurring components of certain foods when cooked at high temperatures, such as French fries and potato chips. Intake from environmental media such as drinking water or air and exposures during use of consumer products are very low in comparison.

Based principally upon weight-of-evidence assessments of international and other national agencies, a critical effect for the characterization of risks to human health is carcinogenicity. Increased incidences of tumours were observed at more than one site in two species of experimental animals exposed by oral administration. Acrylamide was genotoxic in a wide range of in vivo and in vitro assays. While the mode of induction of tumours by acrylamide has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals have resulted from direct interaction with genetic material. In addition, the margin between the upper bounding estimate of intake of acrylamide by the general population and critical effect levels for neurological and reproductive/developmental toxicity in experimental animals may not be adequately protective.

On the basis of the carcinogenic potential of acrylamide, for which there may be a probability of harm at any level of exposure, as well as the potential inadequacy of margins between estimated exposure and critical effect levels for non-cancer effects, it is proposed to conclude that acrylamide is a substance that may be 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.

Based on the information presented for the ecological assessment, it is proposed to conclude that acrylamide is 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 constitutes or may constitute a danger to the environment upon which life depends. In addition, acrylamide does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the Domestic Substances List inventory update initiative. In addition, and where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of potential control measures identified during the risk management phase.

Proposed conclusion

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

The draft Screening Assessment Report as well as the proposed risk management scope document for this substance are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Ethanol, 2-chloro-, phosphate (3:1) [TCEP], CAS No. 115-96-8 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas TCEP is a substance 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 Report conducted on TCEP pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that TCEP meets 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 propose to recommend to Her Excellency the Governor in Council that TCEP be added to Schedule 1 to the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a risk management scope document for this substance 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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Ethanol, 2-chloro-, phosphate (3:1)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Ethanol, 2-chloro-, phosphate (3:1) [Tris(2-chloroethyl phosphate or TCEP], Chemical Abstracts Service Registry Number 115-96-8. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. TCEP was identified as a high priority as it was considered to pose intermediate potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of carcinogenicity. The substance did meet the ecological categorization criteria for persistence, but did not meet the ecological categorization criteria for bioaccumulation potential and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of TCEP relates to human health risks.

Based on empirical data for persistence in water, TCEP is expected to be persistent in the environment. However, experimental and modelled data indicate that this substance does not have a high potential to accumulate in the environment. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

According to information reported under section 71 of CEPA 1999, TCEP was imported into Canada in 2006 in a quantity ranging between 10 000 and 100 000 kg. TCEP is used as a plasticizer and viscosity regulator with flame retardant properties in polyurethanes, polyester resins, polyacrylates and other polymers. These polymers may be used in furniture, building (e.g. roofing insulation) and textile industries (e.g. back-coatings for carpets and upholstery), in some electronic products and in the manufacture of cars.

TCEP has been identified in indoor and outdoor air, dust, drinking water, surface and ground water as well as in various food products. It has also been detected in polyurethane foam that may be found in furniture or mattresses in Canadian homes.

Based on the weight-of-evidence-based assessments of international and other national agencies and taking into consideration more recent data, the critical effects for the characterization of risks to human health for TCEP are carcinogenicity and impaired fertility. Carcinogenic effects included kidney tumours in rats and mice, thyroid tumours in rats and liver, forestomach and harderian gland tumours, and leukemia in mice. Mixed results were obtained in the limited in vivo and in vitro genotoxicity assays in mammalian cells identified. Therefore, based on the range of tumours observed in multiple species of experimental animals for which the mode(s) of induction has(have) not been elucidated, it cannot be precluded that TCEP induces tumours via a mode of action involving direct interaction with genetic material.

Non-neoplastic effects were also observed in the liver and/or kidneys of rats in repeated dose in long term studies. In addition, TCEP impaired fertility in mice and induced testicular toxicity in both mice and rats. Based on comparison of estimated exposures to TCEP in Canada to the critical effect level for non-cancer effects, a dose which was also associated with increased incidences of tumours in a long term study in rats, and taking into account the uncertainties in the databases on exposure and effects, it is considered that the resulting margins of exposure, particularly from products containing the substance, may not be adequately protective of human health.

On the basis of the carcinogenic potential of TCEP, for which there may be a probability of harm at any exposure level, as well as the potential inadequacy of the margins between estimated exposure and critical effect levels for non-cancer effects, it is proposed to conclude that TCEP is a substance that may be 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.

On the basis of low ecological hazard and very low environmental exposure, it is proposed to conclude that TCEP is 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. TCEP meets the criteria for persistence but does not meet the criteria for bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of potential control measures identified during the risk management phase.

Proposed conclusion

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

The draft Screening Assessment Report as well as the proposed risk management scope document for this substance are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]amino]- (Disperse Orange 30), CAS No. 5261-31-4 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas Disperse Orange 30 is a substance 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 Report conducted on Disperse Orange 30 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Orange 30 does not meet any 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 propose to take no further action on Disperse Orange 30 at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]amino]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2,6-dichloro-4-nitrophenyl) azo]phenyl]amino]- (Disperse Orange 30), Chemical Abstracts Service Registry Number 5261-31-4. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Orange 30 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Disperse Orange 30 is an organic substance that is used in Canada and elsewhere as an orange colourant dye mainly in textiles and fabric. The substance is not naturally produced in the environment. Between 1 000 and 10 000 kg of Disperse Orange 30 were imported into Canada in 2006 for use mainly as a colourant in the chemical product manufacturing, textile and fabric finishing, and fabric coating mills industry. Three companies reported importing Disperse Orange 30 into Canada in 2005 with two companies in the 100–1 000 kg/year range, and one company in the 1 001–100 000 kg/year range. The quantity of Disperse Orange 30 imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance is expected to end up in solid waste disposal sites and a significant proportion is estimated to be released to sewer water (14.8%). Disperse Orange 30 is not expected to be soluble in water or to be volatile; it is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, Disperse Orange 30 will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Orange 30 is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to its bioaccumulation potential suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for Disperse Orange 30 as well as for chemical analogues suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharge of Disperse Orange 30 into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Disperse Orange 30 does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-bromo-4,6-dinitrophenyl)azo]-4-ethoxyphenyl]- (Disperse Blue 79), CAS No. 12239-34-8 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas Disperse Blue 79 is a substance 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 Report conducted on Disperse Blue 79 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Blue 79 does not meet any 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 propose to take no further action on Disperse Blue 79 at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-bromo-4,6-dinitrophenyl)azo]-4-ethoxyphenyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-bromo-4,6-dinitrophenyl)azo]4-ethoxyphenyl]- (Disperse Blue 79), Chemical Abstracts Service Registry Number 12239-34-8. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Blue 79 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Disperse Blue 79 is an organic substance that is used in Canada and elsewhere as a blue colourant dye mainly in textiles and fabric. The substance is not naturally produced in the environment. Between 1 000 and 10 000 kg of Disperse Blue 79 were imported into Canada in 2006, for use as a colourant mainly in the chemical product manufacturing and textile and fabric finishing industries. The quantity of Disperse Blue 79 imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance is expected to end up in waste disposal sites (85.2%) but a significant proportion is, however, estimated to be released to sewer water (14.8%). Disperse Blue 79 is not expected to be soluble in water or to be volatile, but it is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, Disperse Blue 79 will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Blue 79 is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for Disperse Blue 79 suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance discharged Disperse Blue 79 into the aquatic environment. The predicted environmental concentrations predicted with this exposure scenario was similar to a previous concentration found in the Canadian aquatic environment. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Disperse Blue 79 does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2-chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]- (ANAM), CAS No. 16421-40-2 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas ANAM is a substance 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 Report conducted on ANAM pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that ANAM does not meet any 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 propose to take no further action on ANAM at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2[(2-chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2-chloro-4,6-dinitrophenyl)azo]-4-methoxyphenyl]- (ANAM), Chemical Abstracts Service Registry Number 16421-40-2. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

ANAM was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

ANAM is an organic substance that is used in Canada and elsewhere as a colourant dye mainly in textiles and fabric industry. The substance is not naturally produced in the environment. Between 100 and 1 000 kg of ANAM were imported into Canada in 2006, for use mainly in the synthetic dye and manufacturing industry. The quantity of ANAM imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance is expected to end up in solid waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). ANAM is not expected to be soluble in water or to be volatile, but it is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, ANAM will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, ANAM is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue of ANAM suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for a chemical analogue suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharges of ANAM into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that ANAM does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2,4-dinitrophenyl)azo]-4-methoxyphenyl]- (AADM), CAS No. 16421-41-3 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas AADM is a substance 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 Report conducted on AADM pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that AADM does not meet any 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 propose to take no further action on AADM at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2,4-dinitrophenyl)azo]-4-methoxyphenyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Acetamide, N-[5-[[2-(acetyloxy)ethyl](phenylmethyl)amino]-2-[(2,4-dinitrophenyl)azo]-4-methoxyphenyl]- (AADM), Chemical Abstracts Service Registry Number 16421-41-3. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance AADM was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

AADM is an organic substance that was previously used in Canada as a colourant dye probably in textiles and fabric based on use codes from the 1986 Domestic Substances List. The substance is not naturally produced in the environment. No companies reported manufacturing, importing or using this substance in Canada above the reporting thresholds in 2005 or 2006. However the threshold of 100 kg was used throughout this screening assessment to capture potential mass of this substance in use in Canada that would be below the threshold reporting value.

Based on certain assumptions and reported use patterns for similar disperse azo dyes, when used, most of the substance is expected to end up in solid waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). AADM is not expected to be soluble in water or to be volatile; it is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, AADM will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, AADM is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue of AADM suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for a chemical analogue, suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharges of AADM into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that AADM does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Ethanol, 2,2′ -[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl]imino]bis- (Disperse Brown 1:1), CAS No. 17464-91-4 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas Disperse Brown 1:1 is a substance 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 Report conducted on Disperse Brown 1:1 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Brown 1:1 does not meet any 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 propose to take no further action on Disperse Brown 1:1 at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Ethanol, 2,2′-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]3-chlorophenyl]imino]bis-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Ethanol, 2,2′-[[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]-3-chlorophenyl] imino]bis- (Disperse Brown 1:1), Chemical Abstracts Service Registry Number 17464-91-4. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Brown 1:1 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Disperse Brown 1:1 is an organic substance that has been previously used in Canada and elsewhere as a colourant dye mainly in textiles. The substance is not naturally produced in the environment. No information on manufacturing, importation or use of this substance was reported for 2006. However, the threshold of 100 kg was used throughout this screening assessment to capture potential mass of this substance in use in Canada that would be below the threshold reporting value.

Based on certain assumptions and reported use patterns of other disperse azo dyes used in the textile industry, most of the substance is expected to end up in solid waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%) Disperse Brown 1:1 is not expected to be soluble in water or to be volatile but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, Disperse Brown 1:1 will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Brown 1:1 is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue of Disperse Brown 1:1 suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for a chemical analogue suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two very conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharges of Disperse Brown 1:1 into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Disperse Brown 1:1 does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Ethanol, 2,2′-[[3-chloro-4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]imino]bis- (Disperse Brown 1), CAS No. 23355-64-8 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas Disperse Brown 1 is a substance 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 Report conducted on Disperse Brown 1 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Brown 1 does not meet any 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 propose to take no further action on Disperse Brown 1 at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Ethanol, 2,2′-[[3-chloro-4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]imino]bis-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Ethanol, 2,2′-[[3-chloro-4-[(2,6-dichloro-4-nitrophenyl)azo]phenyl]imino] bis- (Disperse Brown 1), Chemical Abstracts Service Registry Number 23355-64-8. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Brown 1 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Disperse Brown 1 is an organic substance that was previously used in Canada and elsewhere as a colourant dye mainly in textiles and fabric. The substance is not naturally produced in the environment. No information on manufacturing, importation or use of this substance was reported for 2006. However, the threshold of 100 kg was used throughout this screening assessment to capture potential mass of this substance in use in Canada that would be below the threshold reporting value.

Based on certain assumptions and reported use patterns for other disperse azo dyes used in the textile sector, when used, most of the substance is expected to end up in solid waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). Disperse Brown 1 is not expected to be soluble in water or to be volatile, but it is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, Disperse Brown 1 will likely end up mostly in sediments and, to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Brown 1 is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a close structural analogue of Disperse Brown 1 suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for a chemical analogue suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharges of Disperse Brown 1 into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Disperse Brown 1 does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Propanamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2[(2-chloro-4-nitrophenyl)azo]phenyl]- (Disperse Red 167), CAS No. 26850-12-4 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas Disperse Red 167 is a substance 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 Report conducted on Disperse Red 167 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Red 167 does not meet any 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 propose to take no further action on Disperse Red 167 at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Propanamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-chloro-4-nitrophenyl)azo]phenyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Propanamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(2-chloro-4-nitrophenyl)azo]phenyl]- (Disperse Red 167), Chemical Abstracts Service Registry Number 26850-12-4. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Red 167 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Disperse Red 167 is an organic substance that is used in Canada and elsewhere as a red colourant, mainly in textiles and fabric. The substance is not naturally produced in the environment. A quantity of 1 010 kg of Disperse Red 167 was imported into Canada in 2006, for use mainly in the textile and fabric finishing industry. The quantity of Disperse Red 167 imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance is predicted to end up in solid waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). Disperse Red 167 is not expected to be soluble in water or to be volatile, but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to sewer water, Disperse Red 167 will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Red 167 is expected to be persistent in the environment (for water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of an analogue suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharges of Disperse Red 167 into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentrations calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Disperse Red 167 does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Benzamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(4-nitrophenyl)azo]phenyl]- (BANAP), CAS No. 29765-00-2 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas BANAP is a substance 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 Report conducted on BANAP pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that BANAP does not meet any 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 propose to take no further action on BANAP at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Benzamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2[(4-nitrophenyl)azo]phenyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Benzamide, N-[5-[bis[2-(acetyloxy)ethyl]amino]-2-[(4-nitrophenyl) azo]phenyl]- (BANAP), Chemical Abstracts Service Registry Number 29765-00-2. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance BANAP was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

BANAP is an organic substance that is used in Canada and elsewhere as a red colourant dye mainly in textiles and fabric. The substance is not naturally produced in the environment. Between 100 and 1 000 kg of BANAP were imported into Canada in 2006 and 1 001 to 100 000 kg were imported in 2005. The quantity of BANAP imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance is expected to end up in waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). BANAP is not expected to be soluble in water or to be volatile but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, BANAP will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, BANAP is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue of BANAP suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for a chemical analogue suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, two conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharge of BANAP into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentrations calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that BANAP does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]- (BDAP), CAS No. 52697-38-8 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas BDAP is a substance 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 Report conducted on BDAP pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that BDAP does not meet any 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 propose to take no further action on BDAP at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]- (BDAP), Chemical Abstracts Service Registry Number 52697-38-8. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance BDAP was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

BDAP is an organic substance that is used in Canada primarily as a black dye in textiles and fabrics. The substance is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, between 10 000 and 100 000 kg of the dye were imported into the country in 2006 for use in the textile and fabric finishing industry.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in solid waste disposal sites. A significant amount is however estimated to be released to sewer water (14.8%). BDAP is not expected to be soluble in water or volatile, but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water BDAP will likely end up mostly in sediments, and possibly to a much lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, BDAP is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue suggests that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that BDAP does not cause acute harm to aquatic organisms at low concentrations (< 1 mg/L).

For this screening assessment, a very conservative exposure scenario was developed in which an industrial operation (i.e. the largest importer of the dye) discharges BDAP into a relatively small receiving water body at one discharge point. The predicted environmental concentration in water was below the predicted no-effect concentrations calculated for sensitive species. Additionally, since BDAP may be used in consumer products, a conservative consumer release scenario was also developed based on an estimate of the quantity of BDAP in Canadian commerce. This scenario indicated that all modelled watercourses would have predicted environmental concentrations in water below the predicted no-effect concentrations for sensitive aquatic species.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that BADAP does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Propanenitrile, 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]- (Disperse Orange 61), CAS No. 55281-26-0 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas Disperse Orange 61 is a substance 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 Report conducted on Disperse Orange 61 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Orange 61 does not meet any 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 propose to take no further action on Disperse Orange 61 at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Propanenitrile, 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Propanenitrile, 3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl] ethylamino] (Disperse Orange 61), Chemical Abstracts Service Registry Number 55281-26-0. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance Disperse Orange 61 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Disperse Orange 61 is an organic substance that is used in Canada and elsewhere as a colourant dye mainly in textiles and fabric. The substance is not naturally produced in the environment. Between 1 000 and 10 000 kg of Disperse Orange 61 were imported into Canada in 2006, for use mainly as a colourant in manufacturing textiles, chemical product manufacturing and synthetic dye and pigment manufacturing. The quantity of Disperse Orange 61 imported into Canada, along with the potentially dispersive uses of this substance, indicate that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance is predicted to end up in solid waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). Disperse Orange 61 is not expected to be soluble in water or to be volatile, but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, Disperse Orange 61 will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, Disperse Orange 61 is expected to be persistent in the environment (for water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of an analogue suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for a chemical analogue suggest that the substance does not cause acute harm to aquatic organisms at low concentrations.

For this screening assessment, very conservative exposure scenarios were selected in which industrial operations (users of the dye) and consumer use of products containing this substance resulted in discharge of Disperse Orange 61 into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentrations calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that Disperse Orange 61 does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Ethanol, 2,2′ -[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]imino]bis-, diacetate (ester) [EDD], CAS No. 55619-18-6 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas EDD is a substance 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 Report conducted on EDD pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that EDD does not meet any 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 propose to take no further action on EDD at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Ethanol, 2,2′-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]imino]bis-, diacetate (ester)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on the substance Ethanol, 2,2′-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl] imino]bis-, diacetate (ester) [EDD], Chemical Abstracts Service Registry Number 55619-18-6. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance EDD was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

EDD is an organic substance that has previously been reported to be used in Canada as a colourant dye. The substance is not naturally produced in the environment. No information on manufacturing, importation or use of this substance was reported for 2006. However, the threshold of 100 kg was used throughout this screening assessment to capture the maximum potential mass of this substance that could be in use in Canada given the threshold reporting value. Based on known use patterns of structurally similar azo dyes, the assumption made in this assessment is that EDD is used in textiles.

Based on certain assumptions and reported use patterns of similar disperse azo dyes, most of the substance is predicted to end up in waste disposal sites. A significant proportion is, however, estimated to be released to sewer water (14.8%). EDD is not expected to be soluble in water or to be volatile but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, EDD will likely end up mostly in sediments, and to a lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, EDD is expected to be persistent in the environment (for water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue of EDD suggest that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that the substance does not cause acute harm to aquatic organisms at low concentrations (< 1 mg/L).

For this screening assessment, two very conservative exposure scenarios were selected in which an industrial operation (user of the dye) and consumer use of products containing this substance resulted in discharge of EDD into the aquatic environment. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for sensitive aquatic organisms.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that EDD does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Benzenamine, 4-[(2,6-dichloro-4-nitrophenyl)azo]-N-(4-nitrophenyl)- (DNAN), CAS No. 72927-94-7 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas DNAN is a substance 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 Report conducted on DNAN pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that DNAN does not meet any 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 propose to take no further action on DNAN at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment on Benzenamine, 4-[(2,6-dichloro-4-nitrophenyl)azo]-N-(4-nitrophenyl)-)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Benzenamine, 4-[(2,6-dichloro-4-nitrophenyl)azo]-N-(4-nitrophenyl)- (DNAN), Chemical Abstracts Service Registry Number 72927-94-7. This substance was identified as a high priority for screening assessment and included in the Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and is believed to be in commerce in Canada.

The substance DNAN was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List. Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

DNAN is an organic substance that has been previously reported to be used in Canada as a colourant. The substance is not naturally produced in the environment. No manufacturing or importation of this substance in Canada was reported for the years 2005 and 2006 above the section 71 reporting threshold of 100 kg per year. Based on known use patterns of structurally similar azo dyes, the assumption is made in this assessment that DNAN is used in textiles.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in solid waste disposal sites (85.2%) but a significant amount is released to sewer water (14.8%). DNAN is not expected to be soluble in water or volatile, but is expected to partition to particles because of its hydrophobic nature. For these reasons, after release to water, DNAN will likely end up mostly in sediments, and possibly to a much lesser extent, in agricultural soil that has been amended with sewage sludge. It is not expected to be significantly present in other media. It is also not expected to be subject to long-range atmospheric transport.

Based on its physical and chemical properties, DNAN is expected to be persistent in the environment (in water, sediment and soil). However, new experimental data relating to the bioaccumulation potential of a relatively close structural analogue suggests that this dye has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, experimental toxicity data for chemical analogues suggest that DNAN does not cause acute harm to aquatic organisms at low concentrations (< 1 mg/L).

For this screening assessment, a very conservative exposure scenario was developed in which an industrial operation (i.e. the largest importer of the dye) discharges DNAN into a relatively small receiving water body at one discharge point. The predicted environmental concentration in water was below the predicted no-effect concentrations calculated for sensitive aquatic species. Additionally, since DNAN may be used in consumer products, a conservative consumer release scenario was developed based on an estimate of the quantity of DNAN in Canadian commerce. This scenario indicated that all modelled watercourses would have predicted environmental concentrations below the predicted no-effect concentrations.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will be undertaken to confirm assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that DNAN does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Phosphoric acid tributyl ester (TBP), CAS No. 126-73-8 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas TBP is a substance 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 Report conducted on TBP pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that TBP does not meet any 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 propose to take no further action on TBP at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Phosphoric acid tributyl ester

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Phosphoric acid tributyl ester (TBP), Chemical Abstracts Service Registry Number 126-73-8. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. TBP was identified as a high priority as it was considered to pose intermediate potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of carcinogenicity. The substance did meet the ecological categorization criteria for persistence, but did not meet the ecological categorization criteria for bioaccumulation potential and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of TBP relates to human health risks.

According to information submitted under section 71 of CEPA 1999 responses, TBP was not manufactured in Canada in the calendar year of 2006 above the reporting threshold of 100 kg/year. Some importation activities were reported at a total quantity of approximately 260 000 kg in 2006.

TBP has been identified in indoor air and drinking water in Canada. Recent data are available for other environmental media in other countries. In Canada, the major use of TBP is industrial; it is used in aviation hydraulic fluid, as an extraction solvent for rare earth metals from ores, and as an aid in the manufacture of uranium trioxide. Its industrial use also includes as a defoamer, a plasticizer, and in hydraulic fluid and coatings. It is found in some paints and brake fluids to which the general population of Canada may be exposed during their use.

Based on consideration of relevant available information, including weight-of-evidence-based assessments by international and national agencies, a critical effect for the characterization of risk to human health for TBP is carcinogenicity. Tumours in urinary bladder were observed in male and female rats following dietary exposure at the highest dose tested. Tumours in liver were also observed in male mice. TBP did not show any genotoxicity from bioassays in bacteria, cultured mammalian cells or animals. Mechanistic study and evaluations from other international and national agencies suggest TBP is a non-genotoxic carcinogen and tumours are associated with cytotoxicity and proliferative effects.

Based on comparison of non-neoplastic effects (bladder hyperplasia) and the upper bounding estimates of exposure to TBP from environmental media and during the use of consumer products by the general population in Canada, the resulting margins of exposure are considered adequate to account for uncertainties in the exposure and effects database.

On the basis of the consideration of the existence of a practical threshold for carcinogenicity of TBP in the animal studies, considering the magnitude of the margins of exposure for effects, it is proposed to conclude that TBP is 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.

On the basis of ecological hazard and reported releases of TBP, it is proposed to conclude that TBP is 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. TBP does not meet the criteria for persistence or bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that TBP does not meet the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Acetamide, N,N-dimethyl- (DMAc), CAS No. 127-19-5 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas DMAc is a substance 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 Report conducted on DMAc pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that DMAc does not meet any 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 propose to take no further action on DMAc at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Acetamide, N,N-dimethyl-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Acetamide, N,N-dimethyl-, (DMAc), Chemical Abstracts Service Registry Number 127-19-5. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. DMAc was identified as a high priority as it was considered to pose intermediate potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of developmental toxicity. The substance did not meet the ecological categorization criteria for persistence, bioaccumulation potential or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of DMAc relates to human health risks.

In response to a notice issued under section 71 of CEPA 1999, DMAc was not manufactured in Canada in 2006 above the reporting threshold of 100 kg. The total quantity imported into Canada in the same calendar year was reported to be in the range of 1 000–10 000 kg. Less than 100 kg of DMAc was released to air, water or land in the 2006 calendar year. The principal uses of DMAc include polymer dissolution in the man-made fibre production industry, photoresist stripper in the manufacture of electronic components, production solvent in the pharmaceutical, photography and cosmetic industries, feedstock in the coating industry and sealant applications in aircraft.

Population exposure to DMAc from the general environment is expected to be low based on very limited information on concentrations in environmental media and the results of fugacity modelling. DMAc is used primarily in industrial settings, and consumer exposure to DMAc is not expected to be significant. Based on its uses, any resulting population exposure to residual DMAc is expected to be predominantly via indoor air.

The health effects associated with exposure to DMAc are primarily developmental toxicity and liver toxicity based on observations in experimental animals. The margins between upper-bounding estimates of exposure from environmental media (drinking water and indoor air) and consumer products (textiles and building materials) and levels associated with effects in experimental animals are considered to be adequately protective.

On the basis of the adequacy of the margins between conservative estimates of exposure to DMAc and critical effect levels in experimental animals, it is proposed to conclude that DMAc is 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.

On the basis of ecological hazard and reported releases of DMAc, it is proposed to conclude that this substance is 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. DMAc does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that DMAc does not meet the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Whereas formamide is a substance 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 Report conducted on formamide pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that formamide does not meet any 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 propose to take no further action on formamide at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Formamide

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of formamide, Chemical Abstracts Service Registry Number 75-12-7. The substance formamide was identified in the categorization of the Domestic Substances List as a high priority for action under the Challenge. The substance formamide was identified as a high priority, as it was considered to pose intermediate potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of reproductive toxicity. The substance did not meet the ecological categorization criteria for persistence, bioaccumulation potential or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of formamide relates to human health risks.

There are no known natural sources of formamide. It may be emitted to the environment as a result of its use as an intermediate and solvent. It is used in the crystallization of pharmaceuticals, soil stabilization, a solvent in inks and a component of liquid fertilizers. It is a monomer in the production of polymers such as heat-resistant coatings and some personal care products.

Due to its primary use in industrial settings, the general population is not expected to be exposed to formamide. Exposure is possible from ink in marking pens, where it has been used as a solvent. However, the extent of use of formamide in marking pens in Canada is not known.

Based principally on the weight-of-evidence-based assessments of international or national agencies, critical effects for the characterization of risk to human health for formamide are carcinogenicity and developmental toxicity. In the standard two-year carcinogenicity studies with rats and mice, induced tumours were observed only in one organ (liver), one gender (male) and one species (mice). Based on the weight-of-evidence of the available genotoxicity data, formamide is not mutagenic. Although the mode of induction of tumours has not been developed and elucidated, the tumours observed in the experimental animals are likely not the result of direct interaction with genetic materials.

The non-cancer critical effects for characterization of risk to human health for formamide are reproductive, developmental and haematological toxicity. The exposures of general population to formamide through environment media or consumer products are expected to be low. Comparison of the critical effect level for repeated dose effects with the upper-bounding estimate of intake of formamide yields a margin of exposure that is considered to be adequately protective for non-cancer effects.

On the basis of the consideration of the existence of a practical threshold for non-mutagenic carcinogenicity of formamide in the animals studies, considering the magnitude of the margins of exposure for non-cancer effects, it is proposed that formamide be considered as a substance that is 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.

On the basis of ecological hazard and low reported releases of formamide, it is proposed to conclude that this substance is 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. Formamide meets the criteria for persistence but not the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the upcoming Domestic Substances List inventory update initiative. In addition the government will continue to monitor new scientific developments in order to confirm the assumptions used during the screening assessment.

Proposed conclusion

Based on the information available, it is proposed to conclude that formamide does not meet any of the criteria set out in section 64 of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Publication after screening assessment of a substance — Acetamide, 2-chloro- (2-chloroacetamide), CAS No. 79-07-2 — specified on the Domestic Substances List [subsection 77(1) of the Canadian Environmental Protection Act, 1999]

Whereas 2-chloroacetamide is a substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas the Ministers of the Environment and of Health have conducted an entry characterization on 2-chloroacetamide as part of the screening assessment pursuant to section 74 of that Act;

Whereas a summary of the draft entry characterization of 2-chloroacetamide is annexed hereto;

Whereas it is proposed to conclude that 2-chloroacetamide does not meet any of the criteria set out in section 64 of the Act; and

Whereas the Minister of the Environment intends to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that subsection 81(3) thereof applies with respect to this substance,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on 2-chloroacetamide at this time under section 77 of the Act.

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, 1-800-410-4314 or 819-953-4936 (fax), or by email to Existing.Substances.Existantes@ec.gc.ca.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY

Director General
Chemical Sectors Directorate
On behalf of the Minister of the Environment
KAREN LLOYD

Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Entry Characterization of Acetamide, 2-chloro-

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of Acetamide, 2-chloro- (2-chloroacetamide), Chemical Abstracts Service Registry Number 79-07-2. The substance 2-chloroacetamide was identified as high priority for screening assessment and was included in the Challenge because it was found to pose a high hazard to human health based on its classification as a reproductive toxicant by the European Commission, and it was considered to present intermediate potential for exposure. To substance 2-chloroacetamide did not meet the ecological categorization criteria for persistence, bioaccumulation, or inherent toxicity to aquatic organisms.

In Canada, 2-chloroacetamide was first registered as a pesticide (material preservative) for use in paint, adhesive, dyestuff, detergent, textile and related industries under the Pest Control Products Act (PCPA) in 1977. This pesticide is currently subject to re-evaluation by the Pest Management Regulatory Agency (PMRA), as required by the PCPA. There is currently only one registered product containing 2-chloroacetamide for use as a material preservative and this use is being discontinued by the registrant.

An industrial survey conducted under section 71 of CEPA 1999 revealed only one non-pesticidal use of this substance in Canada above the reporting threshold of 100 kg in 2006. However, further available data indicates that this use is specialized and that the product it is used in may no longer be imported into Canada by the submitter of the information. Additional searches for this substance were conducted up to November 2008, and no information was found on current non-pesticidal uses or releases of this substance in Canada. Therefore, the likelihood of exposure to this substance in Canada resulting from non-pesticidal uses is low.

Since no uses or releases of the above substance other than those covered by the PCPA have been identified in Canada, no additional efforts were made under CEPA 1999 to collect or analyze information relevant to the persistence, bioaccumulation, and inherent toxicity to human and non-human organisms of this substance beyond what was done for categorization on the Domestic Substances List.

The substance 2-chloroacetamide is considered to be inherently toxic to humans as it has been classified by other agencies on the basis of reproductive toxicity. The substance is not considered to be inherently toxic to aquatic organisms (median lethal concentration or median effective concentration < 1 mg/L) and it does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

The re-evaluation of the pesticide 2-chloroacetamide was announced in April 2003, at which time PMRA requested additional information from the registrant in order to conduct a full health and environmental risk assessment. Based on its limited use pattern in Canada, the registrant decided to discontinue all uses of this pesticide and the last date of use for this product is December 31, 2009. Once a registrant discontinues all uses of a pesticide, it is no longer relevant for PMRA to continue to re-evaluate the health and environmental risks. In future, should the registrant decide to reinstate the old product or to register a new product containing 2-chloroacetamide, a full health and environmental risk assessment would be required before the product could be sold or used in Canada.

Proposed conclusion

Based on available information, and until new information is received indicating that the substance is entering or may enter the environment as a result of applications in Canada not registered under the PCPA, it has been determined that 2-chloroacetamide is currently not entering, nor is it likely to enter, the environment from applications not registered under the PCPA. Therefore, it is proposed to conclude that 2-chloroacetamide does not meet the definition of “toxic” set out in section 64 of CEPA 1999.

As 2-chloroacetamide is a substance listed on the Domestic Substances List, its import and manufacture in Canada are not subject to notification under subsection 81(1) of CEPA 1999. Given the hazardous properties of this substance, there is concern that new activities for the substance (other than those covered under the PCPA), which have not been identified or assessed under CEPA 1999, could lead to the substance meeting the criteria set out in section 64 of the Act. Therefore, it is proposed to conclude that 2-chloroacetamide is subject to the Significant New Activity provisions specified under subsection 81(3) of CEPA 1999.

The draft Screening Assessment Report for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).