Vol. 142, No. 34 — August 23, 2008

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after Screening Assessment of Substances — Batch 3

Whereas 2-MEA 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 2-MEA pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that 2-MEA 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 2-MEA 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Ethanol, 2-methoxy-, acetate

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-methoxy-, acetate (2-Methoxyethanol Acetate, 2-MEA), Chemical Abstracts Service Registry Number 110-49-6. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. The substance 2-MEA was identified as a high priority as it was considered to pose an intermediate potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of reproductive and developmental toxicity. The substance did not meet the ecological categorization criteria for persistence and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of 2-MEA relates to human health risks.

According to the information submitted under section 71 of CEPA 1999, 2-MEA was not manufactured in or imported into Canada by any company at a quantity greater than a reporting threshold of 100 kg in the calendar year 2006, although some importation below this threshold was reported. Based on this information, exposure of the general population in Canada to 2-MEA is expected to be very low.

Based on available information from toxicological studies in experimental animals and epidemiological investigations in occupationally exposed populations for 2-MEA and its ethanol analogue, 2-methoxyethanol (2-ME) [in light of the limited database on 2-MEA, the rapid conversion of the acetate to the ethanol and the common profile of effects between the two substances], the critical health effects associated with exposure are primarily developmental and reproductive toxicity (including severe and irreversible teratogenic effects), with effects being observed at very low doses, often the lowest dose tested. In addition, these substances have indicated some potential to interact with genetic material in germ cells. Thus, it cannot be precluded that there is some probability of harm at any level of exposure.

Although exposure to 2-MEA in Canada is likely very low, based principally on the non-distinguishable hazard potential between 2-MEA and 2-ME, including reproductive and developmental effects for which there may be a probability of harm at any level of exposure, it is proposed that the conclusion of the Priority Substance List assessment for 2-ME [i.e. that “on the basis principally of its high health hazard potential, 2-ME is considered to constitute a danger in Canada to human life or health” (Canada 2002)] be expanded to include its acetate moiety, 2-MEA.

On the basis of ecological hazard and reported releases of 2-MEA, 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. The substance 2-MEA 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, to be launched in 2009. 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 2-MEA 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).

Whereas 2-EEA 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 2-EEA pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that 2-EEA 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 the above substance,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on 2-EEA 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Ethanol, 2-ethoxy-, acetate

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-ethoxy-, acetate (2-Ethoxyethanol Acetate, 2-EEA), Chemical Abstracts Service Registry Number 111-15-9. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. The substance 2-EEA was identified as a high priority as it was considered to pose greatest potential for exposure to individuals in Canada and had been classified by the European Commission on the basis of reproductive and developmental toxicity. The substance did not meet the ecological categorization criteria for persistence and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of 2-EEA relates to human health risks.

According to data submitted in CEPA 1999 section 71 responses, 2-EEA was not manufactured in Canada in 2006 above the reporting threshold of 100 kg/year. The total quantity imported into Canada in the same calendar year was reported to be in the range of 10 000–100 000 kg. Its principal uses include solvents, paints, coatings and cleaning solution for industrial applications.

Population exposure to 2-EEA is expected to be predominantly via the air. Based on very limited information on concentrations in environmental media and the results of fugacity modelling, exposure in the general environment is expected to be low. The substance 2-EEA is primarily used in industrial settings, and consumer exposure to 2-EEA is not expected to be significant. The health effects associated with exposure to 2-EEA are primarily developmental and reproductive toxicity and hematological effects, based on observations in experimental animals and exposed workers. The margins between an upper-bounding estimate of concentrations in indoor air and levels associated with effects in occupationally exposed humans and experimental animals are considered to be adequately protective.

On the basis of the adequacy of the margins between conservative estimates of exposure to 2-EEA from environmental media and critical effect levels in exposed human workers and experimental animals, it is proposed to conclude that 2-EEA 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 2-EEA, 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. The substance 2-EEA does not meet the criteria for persistence or bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

Proposed conclusion

Based on the information available, it is proposed to conclude that 2-EEA does not meet the criteria set out in section 64 of CEPA 1999.

As a substance listed on the Domestic Substances List, import and manufacture of 2-EEA in Canada is not subject to notification under subsection 81(1). Given the hazardous properties of this substance, there is concern that new activities which have not been identified or assessed under CEPA 1999 could lead to 2-EEA meeting the criteria set out in section 64 of the Act. Therefore, we intend to subject 2-EEA to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that new manufacture, import or use of 2-EEA is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act prior to the introduction into Canada.

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 2-methoxypropanol 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 2-methoxypropanol pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that 2-methoxypropanol 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 2-methoxypropanol 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 1-Propanol, 2-methoxy-

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 1-Propanol, 2-methoxy- (2-methoxypropanol), Chemical Abstracts Service Registry Number 1589-47-5. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. The substance 2-methoxypropanol was identified as a high priority as it was considered to pose an 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 and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of 2-methoxypropanol relates to human health risks.

The substance 2-Methoxypropanol is a by-product in the manufacture of commercial propylene glycol monomethyl ether (PGME). According to data submitted under section 71 of CEPA 1999, 2-methoxypropanol was not manufactured in Canada in 2006 above the reporting threshold of 100 kg/year. The total quantity imported into Canada in the same calendar year was reported to be in the range of 10 000–100 000 kg. It is used mainly in industrial solvents and paints. Less than 100 kg of 2-methoxypropanol was reported to be released into the environment.

Population exposure to 2-methoxypropanol in Canada is expected to be predominantly from dermal and inhalation exposure during use of consumer products containing the substance as an impurity. Based on very limited information on releases and concentrations in environmental media as well as the results of fugacity modelling, exposure to 2-methoxypropanol from the general environment is expected to be negligible. The critical health effects associated with exposure to 2-methoxypropanol is primarily developmental toxicity, based on observations in experimental animals. While the margin between measured concentrations in indoor air and concentrations associated with effects in experimental animals is large, margins between conservative upper-bounding estimates of concentrations in indoor air during use of products containing 2-methoxypropanol as an impurity and critical effect levels for developmental effects in experimental animals may not be adequately protective. Although use of some consumer products may result in dermal exposure to 2-methoxypropanol, the margins are greater between the upper-bounding estimates of dermal exposures and the highest dose of the acetate moiety of 2-methoxypropanol (2-methoxypropanol acetate) tested in a developmental toxicity study (in lieu of data on 2-methoxypropanol) at which no effects were observed.

On the basis of the potential inadequacy of the margin between estimated exposure via inhalation during use of some consumer products and critical effect levels for developmental toxicity, it is proposed that 2-methoxypropanol be considered “toxic” as defined in paragraph 64(c) of CEPA 1999; i.e., as a substance that is 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 2-methoxypropanol, 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. The substance 2-methoxypropanol 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, to be launched in 2009. 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 2-methoxypropanol 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).

Whereas Pigment Red 3 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 Pigment Red 3 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Red 3 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 Pigment Red 3 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, Existing Substances Division, Environnement Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]-

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 2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]- (Pigment Red 3), Chemical Abstracts Service Registry Number 2425-85-6. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was found to meet the ecological categorization criteria for persistence and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Pigment Red 3 was considered to be a priority for assessment of potential risks to human health, based on meeting the categorization criteria for greatest potential for exposure. Therefore, this assessment focuses on information relevant to the evaluation of health and ecological risks.

Pigment Red 3 is an organic azo pigment that is used in Canada and elsewhere as a red pigment in paints. The substance is not naturally produced in the environment. Pigment Red 3 was manufactured in Canada in 2006. After export of the manufactured substance, 30 000 to 50 000 kg remained in Canada. In total, six companies reported importing the substance and eight companies reported using it in 2006. The quantity of Pigment Red 3 in commerce in Canada, along with the potentially dispersive uses of this substance, indicates that it could potentially be released into the Canadian environment.

Based on certain assumptions such as reported use patterns, most of the substance ends up in waste disposal sites. Small proportions are estimated to be released to water (4.5%) and soil (1.7%). Pigment Red 3 exists in the environment in particulate form, which is not soluble in water or volatile. For these reasons, Pigment Red 3 is likely to settle by gravity to sediments if released to water and will tend to remain in soils if released to terrestrial environments. 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, Pigment Red 3 is expected to be persistent in the environment. New experimental data relating to its solubility in water and octanol suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance is thus not expected to meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance has negligible to low potential for toxicity to aquatic organisms.

For this screening assessment, a very conservative exposure scenario was designed in which it is assumed that all industrial operations (manufacturers and users of the pigment) discharge Pigment Red 3 into the aquatic environment at one discharge point. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for Daphnia magna. Additionally, since Pigment Red 3 may be used in consumer products, a conservative consumer release scenario was also developed based on the quantity of Pigment Red 3 in commerce. This scenario predicted that all watercourses would have predicted environmental concentrations below the predicted no-effect concentration for Daphnia magna.

Based on the information available, it is proposed to conclude that Pigment Red 3 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.

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 Pigment Red 3 is carcinogenicity. Exposure-related tumours were observed at multiple sites in male and female rats and male mice. Although the mode of induction of tumours has not been elucidated, in light of the equivocal evidence for genotoxicity including some positive mutagenicity and DNA damage from a limited database, a mode of tumour induction involving direct interaction with genetic material cannot be precluded.

On the basis of the carcinogenicity of Pigment Red 3, for which there may be a probability of harm at any level of exposure, it is proposed to conclude that Pigment Red 3 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.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Pigment Red 3 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).

Whereas DEGME 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 DEGME pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that DEGME 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 DEGME 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Ethanol, 2-(2-methoxyethoxy)-

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-(2-methoxyethoxy)- (Diethylene glycol monomethyl ether, DEGME), Chemical Abstracts Service Registry Number 111-77-3. This substance was identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. DEGME was identified as a high priority as it was considered to pose greatest 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 and inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of DEGME relates to human health risks.

According to information reported under section 71 of CEPA 1999, DEGME was imported into Canada in 2006 in a quantity ranging between 1 000 000 and 10 000 000 kg. DEGME is used in various applications and products, including as an additive in jet fuel, a solvent in paints, in floor care products, in brake fluid and in some skin creams and cleansers.

Based on limited information on concentrations in environmental media and results from a survey under section 71 of CEPA 1999, exposure to the general population via the environment is expected to be low. However, exposure to DEGME via inhalation and dermal contact may occur during use of products that contain the substance. The health effects associated with exposure to DEGME are primarily developmental and reproductive toxicity and hematological effects, based on observations in experimental animals. No toxic effects have been observed in the experimental animals via inhalation administration, although the available database is more limited. The margins between measured indoor air concentrations or a conservative upper-bounding estimate of concentrations in indoor air during use of consumer products containing DEGME and the concentrations at which no effects were observed in experimental animals (the highest concentrations tested) are considered to be adequately protective. However, the margins between the upper-bounding estimates of dermal exposure to DEGME from consumer products, taking into consideration frequencies of use and the critical effect levels, particularly for developmental toxicity, in short-term or subchronic studies in experimental animals may not be adequately protective.

On the basis of the potential inadequacy of the margins between conservative estimates of exposure to DEGME during use of consumer products via dermal contact and critical effect levels, particularly for developmental toxicity, in experimental animals, it is proposed that DEGME be considered “toxic” as defined in paragraph 64(c) of CEPA 1999, i.e., as a substance that is 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 DEGME, 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. DEGME 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, to be launched in 2009. 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 DEGME 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).

Whereas Disperse Blue 19, PDDAM and Pigment Red 251 are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment Report conducted on Disperse Blue 19, PDDAM and Pigment Red 251 pursuant to section 74 of the Act is annexed hereby;

Whereas the Ministers of the Environment and of Health have identified no manufacture or importation activity for Disperse Blue 19, PDDAM and Pigment Red 251 above 100 kg per calendar year;

Whereas it is proposed to conclude that Disperse Blue 19, PDDAM and Pigment Red 251 do 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 the above substances,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on Disperse Blue 19, PDDAM and Pigment Red 251 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Draft Screening Assessment of the three substances listed below conducted under section 74 of the Canadian Environmental Protection Act, 1999

*CAS RN = Chemical Abstracts Service Registry Number

The above three substances on the Domestic Substances List (DSL) were identified as high priorities for screening assessment, to be part of the Ministerial Challenge, because they met the ecological categorization criteria for persistence (P) and bioaccumulation (B) and inherent toxicity to non-human organisms (iT), under paragraph 73(1)(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and were believed to be in commerce in Canada. The substances were not considered to be a high priority for assessment of potential risks to human health.

Pursuant to paragraph 74(a) of CEPA 1999, the Ministers of the Environment and of Health have conducted a screening assessment on the three substances.

Results from notices issued under paragraph 71(1)(b) of CEPA 1999 in March 2006 and August 2007 revealed no reports of industrial activity (import or manufacture) with respect to these substances in Canada, above the reporting threshold of 100 kg, for the specified reporting years of 2005 and 2006. These results suggest that these substances are currently not in use above the specified reporting threshold, and therefore the likelihood of exposure to these substances in Canada resulting from commercial activity is low.

Results from the above notices issued under paragraph 71(1)(b) of CEPA 1999 and the accompanying questionnaire of August 2007 also revealed no new information relevant to the PBiT properties of these three substances. Given the lack of any significant commercial activity for these substances, no additional efforts have been made to collect or analyze information relevant to the persistence, bioaccumulation and ecological effects of these three substances beyond what was done for categorization. Therefore, the decisions on PBiT properties made during categorization remain unchanged. The substances are considered to be inherently toxic to non-human organisms. They also meet the criteria for both persistence and bioaccumulation as set out in the Persistence and Bioaccumulation Regulations.

These substances will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment.

Proposed conclusion

Based on available information, and until new information is received indicating that any of these substances is entering, or may enter the environment, it is proposed to conclude that the above three substances are currently not entering, nor are they likely to enter, the environment as a result of commercial activity in Canada. Therefore, it is proposed to conclude that they do not meet the criteria set out in section 64 of CEPA 1999.

As substances listed on the Domestic Substances List, import and manufacture of these three substances in Canada are not subject to notification under subsection 81(1). Given their hazardous PBiT properties, there is concern that new activities for the above three substances which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria set out in section 64 of the Act. Therefore, it is recommended that the above three substances be subject to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that any new manufacture, import or use of these substances in quantities greater than 100 kg/year is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act, prior to the substance being introduced into Canada.

Whereas Disperse Red 86 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 86 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Red 86 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 86 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Benzenesulfonamide, N-(4-amino-9,10-dihydro-3-methoxy9,10-dioxo-1-anthracenyl)-4-methyl-

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 Benzenesulfonamide, N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthracenyl)-4-methyl- (Disperse Red 86), Chemical Abstracts Service Registry Number 81-68-5. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Disperse Red 86 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 86 is a discrete organic substance that is used as a colourant (pigment, stain, dye, ink). The substance is not naturally produced in the environment. Disperse Red 86 was not imported nor manufactured in Canada in 2005. In 2006, between 1 000 and 10 000 kg of Disperse Red 86 were imported, mainly in manufactured products and for application as a textile dye. This substance is not expected to be widely dispersed in the Canadian environment.

Based on certain assumptions and reported use patterns, most of this substance is expected to end up in waste disposal sites and in water. It is not expected to be significantly present in other media. In addition, Disperse Red 86 is not likely to be subject to long-range atmospheric transport.

Disperse Red 86 is a dense solid particle with a limited water solubility. Based on its physical and chemical properties, Disperse Red 86 does not degrade quickly in the environment and is therefore expected to be persistent in water, soil and sediments. Recent experimental data show that Disperse Red 86 has a low potential to accumulate in the lipid tissues of aquatic organisms. The substance therefore meets the persistence criterion but does not meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. Empirical acute aquatic toxicity values of analogues of Disperse Red 86 suggest that the substance is not expected to be inherently toxic to aquatic organisms.

No environmental monitoring data relating to the presence of Disperse Red 86 in the Canadian environment (air, water, soil, sediment) have been identified. For this draft screening assessment, a conservative exposure scenario was designed in which it is assumed that all industrial operations (users of the dye) discharge Disperse Red 86 into the aquatic environment. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for fish (Pimephales promelas).

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 86 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).

Whereas Disperse Violet 57 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 Violet 57 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Violet 57 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 Violet 57 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 9,10-Anthracenedione, 1-hydroxy-4-[[4[(methylsulfonyl)oxy]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 9,10-Anthracenedione, 1-hydroxy-4-[[4-[(methylsulfonyl)oxy] phenyl]amino]- (Disperse Violet 57), Chemical Abstracts Service Registry Number 1594-08-7. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was originally 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 Violet 57 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 Violet 57 is an organic substance that is used in Canada and elsewhere as an intense violet colourant dye in textiles. The substance is not naturally produced in the environment. Between 100 and 1 000 kg of Disperse Violet 57 were imported into Canada in 2006, and between 100 and 1 000 kg were imported in 2005, for use mainly in the textile industry. The quantity of Disperse Violet 57 imported into Canada, along with the potentially dispersive uses of this substance, indicates that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance ends up in waste disposal sites (84.5%) while the remaining portion is estimated to be released to water (16.5%). Disperse Violet 57 is a dense solid particle with a limited water solubility. For these reasons, Disperse Violet 57 will most likely be found in sediments, and to a lesser extent, in soil. 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 Violet 57 does not degrade quickly in the environment and is therefore expected to be persistent in water, soil and sediments. Recent experimental data show that Disperse Violet 57 has a low potential to accumulate in the lipid tissues of aquatic organisms. The substance therefore meets the persistence criterion but does not meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. Empirical acute aquatic toxicity values of analogues of Disperse Violet 57 suggest that the substance is not expected to be inherently toxic to aquatic organisms.

No environmental monitoring data relating to the presence of Disperse Violet 57 in the Canadian environment (air, water, soil, sediment) have been identified. For this screening assessment, a conservative exposure scenario was designed in which it is assumed that all industrial operations (users of the dye) discharge Disperse Violet 57 into the aquatic environment. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for fish (Pimephales promelas).

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Violet 57 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).

Whereas Pigment Red 4 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 Pigment Red 4 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Red 4 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 Pigment Red 4 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenol, 1-[(2-chloro-4-nitrophenyl)azo]-

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 2-Naphthalenol, 1-[(2-chloro-4-nitrophenyl)azo]- (Pigment Red 4), Chemical Abstracts Service Registry Number 2814-77-9. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Pigment Red 4 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.

Pigment Red 4 is an organic substance that is used in Canada and elsewhere as a red pigment in printing inks and paints. The substance is not naturally produced in the environment. Presently, Pigment Red 4 is not manufactured in Canada. In 2006, two companies reported importing Pigment Red 4, in a total quantity range of 1 000 to 10 000 kg/year. The quantity of Pigment Red 4 in commerce in Canada, along with the potentially dispersive uses of this substance, indicates that it could potentially be released into the Canadian environment.

Based on certain assumptions such as reported use patterns, 93% of the substance ends up in waste disposal sites and 4.8% is estimated to be released to water. Pigment Red 4 exists in the environment in particulate form, which is not soluble in water or volatile. For these reasons, Pigment Red 4 is likely to settle by gravity to sediments if released to water, and will tend to remain in soils if released to terrestrial environments. 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, Pigment Red 4 is expected to be persistent in the environment. New experimental data relating to its solubility in water and octanol suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance is thus not expected to meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data on structurally similar pigments, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance has negligible to low potential for toxicity to aquatic organisms.

For this screening assessment, a very conservative exposure scenario was designed in which it is assumed that all industrial operations (users of the pigment) discharge Pigment Red 4 into the aquatic environment at one discharge point. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for Daphnia magna. Additionally, since Pigment Red 4 may be used in consumer products, a conservative consumer release scenario was also developed based on the quantity of Pigment Red 4 in commerce. This scenario predicted that all watercourses would have predicted environmental concentrations below the predicted no-effect concentration for Daphnia magna.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Pigment Red 4 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).

Whereas Pigment Orange 5 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 Pigment Orange 5 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Orange 5 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 Pigment Orange 5 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenol, 1-[(2,4-dinitrophenyl)azo]-

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 2-Naphthalenol, 1-[(2,4-dinitrophenyl)azo]- (Pigment Orange 5), Chemical Abstracts Service Registry Number 3468-63-1. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Pigment Orange 5 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.

Pigment Orange 5 is an organic substance that is used in Canada and elsewhere as an orange pigment in paints and printing inks. The substance is not naturally produced in the environment. In 2006, eleven companies reported importing this substance, in a total quantity ranging from 10 000 to 100 000 kg. Ten companies reported using this substance in 2006, in a total quantity ranging from 10 000 to 100 000 kg. The quantity of Pigment Orange 5 in commerce in Canada, along with the potentially dispersive uses of this substance, indicates that it could potentially be released into the Canadian environment.

Based on certain assumptions such as reported use patterns, most of the substance ends up in waste disposal sites. Small proportions are estimated to be released to water (20%), and soil (3%). Pigment Orange 5 exists in the environment in particulate form, which is not soluble in water or volatile. For these reasons, Pigment Orange 5 is likely to settle by gravity to sediments if released to water, and will tend to remain in soils if released to terrestrial environments. 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, Pigment Orange 5 is expected to be persistent in the environment. New experimental data relating to its solubility in water and octanol suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance is thus not expected to meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance has negligible to low potential for acute toxicity to aquatic organisms.

For this screening assessment, a very conservative exposure scenario was designed in which it is assumed that all industrial operations (users of the pigment) discharge Pigment Orange 5 into the aquatic environment. The predicted environmental concentration in water was below the predicted no-effect concentration calculated for Daphnia magna. Additionally, since Pigment Orange 5 may be used in consumer products, a conservative consumer release scenario was also developed based on the quantity of Pigment Orange 5 in commerce. This scenario predicted that all watercourses would have predicted environmental concentrations below the predicted no-effect concentration for Daphnia magna.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Pigment Orange 5 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).

Whereas Pigment Orange 2 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 Pigment Orange 2 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Orange 2 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 Pigment Orange 2 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenol, 1-[(2-nitrophenyl)azo]-

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 2-Naphthalenol, 1-[(2-nitrophenyl)azo]- (Pigment Orange 2), Chemical Abstracts Service Registry Number 6410-09-9. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it had been found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Pigment Orange 2 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.

Pigment Orange 2 is an organic substance that has been used in Canada and elsewhere as an orange colourant dye in inks, paper, paint coatings and plastics. The substance is not naturally produced in the environment. No companies reported manufacturing or importing Pigment Orange 2 into Canada in the 2005 or 2006 calendar years. Therefore, releases of this substance to the Canadian environment are presumed to be very low.

Pigment Orange 2 exists in the environment in particulate form, which is not soluble in water and is not volatile. For these reasons, Pigment Orange 2 will most likely be found in sediments and will tend to remain in soil if released to terrestrial environments. 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, Pigment Orange 2 is expected to be persistent in the environment. New experimental data relating to the solubility of analogues in water and octanol suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance is thus not expected to meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data on structurally similar pigments, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance has a negligible to low potential for toxicity to aquatic organisms.

A quantitative evaluation of exposure and of ecological effects was conducted as part of the weight-of-evidence evaluation of this pigment’s potential to cause ecological harm. The Industrial Generic Exposure Tool—Aquatic (IGETA), a modelling tool developed by Environment Canada to estimate surface water concentrations, was used. Based upon a conservative, generic scenario, the risk posed by exposure to Pigment Orange 2 was estimated to be low. Considering these findings, it is concluded that Pigment Orange 2 is unlikely to be causing ecological harm in Canada.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Pigment Orange 2 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).

Whereas Pigment Red 6 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 Pigment Red 6 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Red 6 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 Pigment Red 6 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenol, 1-[(4-chloro-2-nitrophenyl)azo]-

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 2-Naphthalenol, 1-[(4-chloro-2-nitrophenyl)azo]- (Pigment Red 6), Chemical Abstracts Service Registry Number 6410-13-5. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Pigment Red 6 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.

Pigment Red 6 is an organic substance that has been used in Canada in the past as a solvent/carrier, printing agent/de-inker and in electrical or electronic products. Elsewhere, it may be used in paints, printing inks, paper, board and plastics, and for colouring leather and textile printing. However, it has lost most of its commercial impact. The substance is not naturally produced in the environment. No reports of the manufacture in or import into Canada of Pigment Red 6 were received for the 2005 or 2006 calendar years. Therefore, releases of this substance to the Canadian environment are presumed to be very low.

Pigment Red 6 exists in the environment in particulate form, which is not soluble in water and is not volatile. For these reasons, Pigment Red 6 will most likely be found in sediments and will tend to remain in soils if released to terrestrial environments. 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, Pigment Red 6 is expected to be persistent in the environment. New experimental data relating to the solubility of analogues in water and octanol suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance is thus not expected to meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data on structurally similar pigments, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that the substance has a negligible to low potential for toxicity to aquatic organisms.

A quantitative evaluation of exposure and of ecological effects was conducted as part of the weight-of-evidence evaluation of this pigment’s potential to cause harm. Based upon a conservative generic scenario, the risk posed by exposure to Pigment Red 6 was estimated to be low. Considering these findings, it is concluded that Pigment Red 6 is unlikely to be causing ecological harm in Canada.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Pigment Red 6 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).

Whereas Pigment Red 5 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 Pigment Red 5 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Pigment Red 5 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 Pigment Red 5 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenecarboxamide, N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulfonyl]-2-methoxyphenyl]azo]-3-hydroxy-

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 2-Naphthalenecarboxamide, N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulfonyl]-2-methoxyphenyl]azo]-3-hydroxy- (Pigment Red 5), Chemical Abstracts Service Registry Number 6410-41-9. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Pigment Red 5 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.

Pigment Red 5 is an organic substance that is used in Canada and elsewhere primarily as a colour pigment in plastics, inks, paints and textiles, and is also used in cosmetics, soaps and detergents, and in the sectors of rubber and fabricated metal products and electronic equipment. The substance is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, 100 kg of the pigment were imported into the country in 2006.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in waste disposal sites. Estimates predict that 1.8% of Pigment Red 5 may be released to soil. No releases are predicted to air, surface water and groundwater. Pigment Red 5 presents low to very low experimental solubilities in water and octanol (< 150 µg/L). It is present in the environment primarily as micro-particulate matter that is not volatile and rather chemically stable, and it has a tendency to partition by gravity to sediments if released to surface waters, and to soils if released to air in terrestrial environments.

Based on its physical and chemical properties, Pigment Red 5 is expected to be persistent in the environment. However, new experimental data relating to its solubility in octanol and water suggest that this pigment has a low potential to accumulate in the lipid tissues of organisms. The substance therefore meets the persistence criterion but does not meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. In addition, new experimental toxicity data for a chemical analogue, as well as new toxicity predictions that take into account revised estimates of bioaccumulation potential, suggest that saturated solutions of the substance do not cause acute harm to aquatic organisms.

Given that 1.8% (only 3.6 kg) of the total mass of Pigment Red 5 is predicted to be released to soil, exposure of this substance to the Canadian environment is presumed to be very low, not resulting in any form of ecotoxicity.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Pigment Red 5 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).

Whereas Acid Blue 127 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 Acid Blue 127 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Acid Blue 127 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 Acid Blue 127 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Anthracenesulfonic acid, 4,4′-[(1-methylethylidene)bis (4,1-phenyleneimino)]bis[1-amino-9,10-dihydro-9, 10-dioxo-, disodium salt

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 2-Anthracenesulfonic acid, 4,4′-[(1-methylethylidene)bis(4,1-phenyleneimino)]bis[1-amino-9,10-dihydro-9,10-dioxo-, disodium salt (Acid Blue 127), Chemical Abstracts Service Registry Number 6471-01-8. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

Acid Blue 127 is a discrete organic substance that is used in Canada and elsewhere as a colourant dye for soap and cleaning products processing. The substance is not naturally produced in the environment and it was not manufactured in or imported into Canada at or above the reporting threshold of 100 kg in 2005 and 2006. However, a stakeholder reported having a potential interest in the future import, manufacture or use of this substance.

Since there were no reports of import or manufacture at or above the reporting threshold of 100 kg in 2005 or 2006, releases of this substance into the Canadian environment are expected to be low.

Based on its physical and chemical properties, Acid Blue 127 does not have the potential to accumulate in aquatic organisms, and empirical acute aquatic toxicity values of analogues of Acid Blue 127 suggest that the substance is not highly hazardous to aquatic organisms. However, Acid Blue 127 does not degrade quickly in the environment. It is expected to be persistent in water, soil and sediments based on criteria defined in the Persistence and Bioaccumulation Regulations.

For this screening assessment, a very conservative exposure scenario was designed in which it is assumed that 100 kg (the reporting threshold) of Acid Blue 127 is used at a single industrial operation (user of the dye) and that a large proportion of the amount used is discharged into the aquatic environment. The predicted environmental concentration in water was well below the predicted no-effect concentration for sensitive aquatic organisms.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Acid Blue 127 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).

Whereas Disperse Blue 77 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 77 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Disperse Blue 77 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 77 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of 9,10-Anthracenedione, 1,8-dihydroxy-4-nitro-5-(phenylamino)-

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 9,10-Anthracenedione, 1,8-dihydroxy-4-nitro-5-(phenylamino)- (Disperse Blue 77), Chemical Abstracts Service Registry Number 20241-76-3. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Disperse Blue 77 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 77 is an organic substance that is used in Canada and elsewhere as a blue colourant dye in textiles. The substance is not naturally produced in the environment. Disperse Blue 77 is not manufactured in Canada but between 100 and 1 000 kg of Disperse Blue 77 were imported into Canada in 2006 for use mainly in the textile industry. The quantity of Disperse Blue 77 imported into Canada suggests that it could potentially be released into the Canadian environment.

Based on certain assumptions and reported use patterns, most of the substance ends up in waste disposal sites (98.4%) while the remaining portion is estimated to be released to water (1.6%) and air (0.1%). Disperse Blue 77 is not soluble in water, is not volatile and has a tendency to partition to particles and lipids (fat) of organisms because of its hydrophobic nature. For these reasons, Disperse Blue 77 will most likely be found in sediments and, to a lesser extent, in soil. 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 77 does not degrade quickly in the environment and is therefore expected to be persistent in water, soil and sediments. Recent bioaccumulation data for Disperse Blue 77 and chemical analogues show that this substance does not have a high potential to accumulate in aquatic organisms. Disperse Blue 77 therefore meets the persistence criterion but does not meet the bioaccumulation criterion as set out in the Persistence and Bioaccumulation Regulations. Empirical acute aquatic toxicity values of analogues of Disperse Blue 77 suggest that the substance is not highly hazardous to aquatic organisms.

No environmental monitoring data relating to the presence of Disperse Blue 77 in the Canadian environment (air, water, soil, sediment) have been identified. For this screening assessment, a very conservative exposure scenario was designed in which it is assumed that all industrial operations (users of the dye) discharge Disperse Blue 77 into the 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 Domestic Substances List inventory update initiative, to be launched in 2009. 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 77 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).

Whereas PBMBDP 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 PBMBDP pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that PBMBDP 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 PBMBDP 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Peroxide, [1,3(or 1,4)-phenylenebis(1-methylethylidene)] bis[(1,1-dimethylethyl)

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 Peroxide, [1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[(1,1-dimethylethyl) [PBMBDP], Chemical Abstracts Service Registry Number 25155-25-3. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance PBMBDP 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. This substance remains subject to further ecological and human health assessment in the future if information is identified that indicates that such evaluation is warranted.

PBMBDP is an organic substance that is used in Canada and elsewhere in polymer processing as an initiator for polymerization. The substance is not naturally produced in the environment. PBMBDP was not manufactured in Canada in 2006, while between 1 000 and 10 000 kg of PBMBDP were imported into Canada in 2006.

Based on certain assumptions and reported use patterns, more than half of the substance is transformed during the processing phase, while substantial amounts are ultimately sent to waste management facilities. Small proportions may be released to water (0.4%). PBMBDP is not soluble in water and has a tendency to partition to particles because of its hydrophobic nature. For these reasons, PBMBDP would likely be found almost entirely in sediments and is not expected to be significantly present in other media.

Based on the expected environmental fate of other similar organoperoxide substances, PBMBDP is not expected to meet the persistence criterion as set out in the Persistence and Bioaccumulation Regulations, but it is predicted to have a potential to accumulate in organisms.

Predicted environmental concentrations are a few orders of magnitude lower than the predicted no-effects concentrations for aquatic organisms.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 PBMBDP 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).

Whereas Acid Violet 48 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 Acid Violet 48 pursuant to section 74 of the Act is annexed hereby; and

Whereas it is proposed to conclude that Acid Violet 48 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 Acid Violet 48 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, Existing Substances Division, Environment Canada, 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
Acting Director General
Safe Environments Programme
On behalf of the Minister of Health

ANNEX

Summary of the Screening Assessment Report of Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo3-[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl] amino]-2,4,6-trimethyl-, disodium salt

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 Benzenesulfonic acid, 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulfo-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthracenyl]amino]-2,4,6-trimethyl-, disodium salt (Acid Violet 48), Chemical Abstracts Service Registry Number 72243-90-4. This substance was identified as a high priority for screening assessment and included in the Ministerial Challenge because it was originally found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and it is believed to be in commerce in Canada.

The substance Acid Violet 48 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.

Acid Violet 48 is a discrete organic chemical that is used in Canada and elsewhere as a colourant dye for textiles as well as a component in cleaning products. In Canada, this substance is primarily imported in already formulated cleaning products and, to a smaller degree, as a pure substance for integration into cleaning products or for use as an acid dye in textiles.

This substance is not naturally produced in the environment. Between 100 and 1 000 kg of Acid Violet 48 were imported into Canada in 2006. Reported uses and the dispersive use patterns of this substance indicate that it could potentially be released into the Canadian environment. It is predicted that most of this substance ends up in water and waste disposal sites. Acid Violet 48 is not expected to be significantly present in other media.

It is now concluded that Acid Violet 48 does not have the potential to bioaccumulate in aquatic organisms based on the review of the available data and the substance’s physical and chemical properties. Furthermore, both empirical and analogue acute aquatic toxicity values suggest that this substance is not hazardous to aquatic organisms. However, Acid Violet 48 does not degrade quickly in the environment and is expected to be persistent in water, soil and sediments. Therefore, this substance has been determined to meet the persistence criteria as set out in the Persistence and Bioaccumulation Regulations.

This substance will be included in the Domestic Substances List inventory update initiative, to be launched in 2009. 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 Acid Violet 48 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).