Vol. 142, No. 27 — July 5, 2008

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of Final Decision on the Screening
Assessment of Substances — Batch 1

Whereas DMHBP 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 final Screening Assessment Report conducted on DMHBP pursuant to section 74 of the Act is annexed hereby; and

Whereas DMHBP 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 DMHBP at this time under section 77 of the Act.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Peroxide, (1,1,4,4-tetramethyl-1,4-butanediyl)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, (1,1,4,4-tetramethyl-1,4-butanediyl)bis[(1,1-dimethylethyl)] (DMHBP), Chemical Abstracts Service Registry No. 78-63-7. This substance was identified as a high priority for screening assessment and was 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 is believed to be in commerce in Canada.

The substance DMHBP 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 (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

DMHBP is an organic substance that is used in Canada and elsewhere in polymer processing. The substance is not naturally produced in the environment. Between 1 000 and 10 000 kg of DMHBP were manufactured in Canada in 2006 while between 10 000 and 100 000 kg of DMHBP were imported into Canada during the same period.

Based on certain assumptions and reported use patterns, most of the substance is transformed during the processing phase. Small proportions may be released to water (0.08%). This substance is not soluble in water and has a tendency to partition to particles because of its hydrophobic nature. For these reasons, DMHBP would likely be found almost entirely in sediments and is not expected to be significantly present in other media.

DMHBP 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 indicates a low probability of risk in the aquatic environment.

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.

Conclusion

Based on the information available, DMHBP does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas DMBP 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 final Screening Assessment Report conducted on DMBP pursuant to section 74 of the Act is annexed hereby; and

Whereas DMBP 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 DMBP at this time under section 77 of the Act.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Peroxide, (1,1,4,4-tetramethyl-2-butyne-1,4-diyl)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, (1,1,4,4-tetramethyl-2-butyne-1,4-diyl)bis[(1,1-dimethylethyl)] (DMBP), Chemical Abstracts Service Registry No. 1068-27-5. 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 is believed to be in commerce in Canada.

The substance DMBP 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 (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

DMBP is an organic substance that is used in Canada and elsewhere in polymer processing. The substance is not naturally produced in the environment. Between 1 000 and 10 000 kg of DMBP were manufactured in Canada in 2006 while between 1 000 and 10 000 kg of DMBP were imported into Canada during the same period.

Based on certain assumptions and reported use patterns, most of the substance is transformed during the processing phase. Small proportions may be released to water (0.1%). DMBP is not soluble in water and has a tendency to partition to particles because of its hydrophobic nature. For these reasons, DMBP would likely be found almost entirely in sediments and is not expected to be significantly present in other media.

DMBP 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 indicates a low probability of risk in the aquatic environment.

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.

Conclusion

Based on the information available, DMBP does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas DBTMC 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 final Screening Assessment Report conducted on DBTMC pursuant to section 74 of the Act is annexed hereby; and

Whereas DBTMC 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 DBTMC at this time under section 77 of the Act.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Peroxide, (3,3,5-trimethylcyclohexylidene)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, (3,3,5-trimethylcyclohexylidene)bis[(1,1-dimethylethyl) [DBTMC], Chemical Abstracts Service Registry No. 6731-36-8. 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 DBTMC 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 (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

DBTMC is an organic substance that is used in Canada and elsewhere in polymer processing and in the hardening of polyester resins. The substance is not naturally produced in the environment. DBTMC was not manufactured in Canada in 2006, while between 10 000 and 100 000 kg of DBTMC were imported into Canada during the same period.

Based on certain assumptions and reported use patterns, most of the substance is transformed during the processing phase. Small proportions may be released to water (0.04%). This substance is not soluble in water and has a tendency to partition to particles because of its hydrophobic nature. For these reasons, DBTMC would likely be found almost entirely in sediments and is not expected to be significantly present in other media.

DBTMC 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 two orders of magnitude lower than the predicted no-effects concentrations for aquatic organisms. This indicates a low probability of risk in the aquatic environment.

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.

Conclusion

Based on the information available, DBTMC does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas CHPD 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 final Screening Assessment Report conducted on CHPD pursuant to section 74 of the Act is annexed hereby;

Whereas CHPD meets one or more of the criteria set out in section 64 of the Act; and

Whereas the Ministers are satisfied that the criteria set out under subsection 77(4) of the Act are met,

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 CHPD be added to Schedule 1 to the Act.

Notice therefore is further given that the Ministers of the Environment and of Health propose the implementation of virtual elimination of CHPD under subsection 65(3) of the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach document.

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy) ethyl]ethylamino]-2-methylphenyl]methylene]-

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 Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]2-methylphenyl]methylene]- (CHPD), Chemical Abstracts Service Registry No. 54079-53-7. 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 is believed to be in commerce in Canada.

The substance CHPD 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 (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

CHPD is an organic substance that is used in Canada and elsewhere as a yellow colorant dye in plastics. The substance is not naturally produced in the environment. Between 100 and 1 000 kg of CHPD were imported into Canada in 2000, and in 2006, for use mainly in the colourants and plastics industry. The quantity of CHPD imported into Canada, along with the mass flow tool information, indicate 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 (3.4%), air (0.4%) and soil (0.2%). CHPD has a very low solubility 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, CHPD will be likely found mostly 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, CHPD does not degrade quickly in the environment. It is therefore expected to be persistent in water, soil and sediments. CHPD also has the potential to accumulate in organisms and may biomagnify in trophic food chains. The substance has been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. In addition, empirical and modelled acute aquatic toxicity values suggest that the substance is highly hazardous to certain aquatic organisms (LOEC/LC₅₀ < 1.0 mg/L).

Given that long-term risks associated with persistent and bioaccumulative substances cannot at present be reliably predicted, quantitative risk estimates have limited relevance. Furthermore, since accumulations of such substances may be widespread and are difficult to reverse, a conservative response to uncertainty is justified.

Based on the information available, it is concluded that CHPD is 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.

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.

Conclusion

Based on the information available, it is concluded that CHPD meets one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999. CHPD is persistent and bioaccumulative in accordance with the regulations, its presence in the environment results primarily from human activity, and it is not a naturally occurring radionuclide or a naturally occurring inorganic substance.

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

Whereas Pigment Orange 38 is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of a final Screening Assessment Report conducted on Pigment Orange 38 pursuant to section 74 of the Act is annexed hereby; and

Whereas Pigment Orange 38 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 38 at this time under section 77 of the Act.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenecarboxamide, N-[4-(acetylamino)phenyl]-4[[5-(aminocarbonyl)-2-chlorophenyl]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-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxy- (Pigment Orange 38), Chemical Abstracts Service Registry No. 12236-64-5. 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 is believed to be in commerce in Canada.

The substance Pigment Orange 38 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 (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Pigment Orange 38 is an organic substance that is used in Canada primarily as a colour pigment in plastics and inks. The substance is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, between 100 and 1 000 kg of the pigment were imported into the country in 2006 for use in the manufacturing of various coloured products.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in waste disposal sites. Assumptions and input parameters used in making these estimates are based on information obtained from a variety of sources including responses to regulatory surveys, Statistics Canada, manufacturers’ Web sites and technical databases. About 5% is estimated to be released to water, and no releases are predicted to air and soil. Pigment Orange 38 presents very low experimental solubilities in water and octanol (new data: range of 10–100 µg/L). It is present in the environment primarily as micro-particulate matter that is not volatile, is 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.

Based on its physical and chemical properties, Pigment Orange 38 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.

For this screening assessment, a very conservative exposure scenario was selected in which an industrial operation (user of the pigment) discharges Pigment Orange 38 into the aquatic environment. The predicted environmental concentration in water was many orders of magnitude below predicted no-effect concentrations calculated for fish, daphnids and algae.

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.

Conclusion

Based on the information available, Pigment Orange 38 does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

The final 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 247:1 is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of a final Screening Assessment Report conducted on Pigment Red 247:1 pursuant to section 74 of the Act is annexed hereby; and

Whereas Pigment Red 247:1 does not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to take no further action on Pigment Red 247:1 at this time under section 77 of the Act.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]-, calcium salt (2:1)

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment on Benzenesulfonic acid, 4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl) amino]carbonyl]-1-naphthalenyl]azo]-4-methylbenzoyl]amino]-, calcium salt (2:1) [Pigment Red 247:1], Chemical Abstracts Service Registry No. 43035-18-3. 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 is believed to be in commerce in Canada.

The substance Pigment Red 247:1 was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed by Health Canada for categorization of substances on the Domestic Substances List (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Pigment Red 247:1 is an organic substance used as a colour pigment in plastics, inks and paints, in the food and beverage sector, and as an inert ingredient in pesticides. In Canada, the only known use is in the plastics sector. The substance is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, between 100 and 1 000 kg of the pigment were imported into the country in 2006 for use in the manufacturing of various coloured products.

Based on certain assumptions and reported use patterns in Canada, most of the substance ends up in waste disposal sites. Assumptions and input parameters used in making these estimates are based on information obtained from a variety of sources including responses to regulatory surveys, Statistics Canada, manufacturers’ Web sites and technical databases. About 3% is estimated to be released to water, and negligible releases are predicted to air and soil. Pigment Red 247:1 presents very low experimental solubilities in water and octanol (< 200 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.

Based on its physical and chemical properties, Pigment Red 247:1 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. Therefore, this substance 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 and new toxicity predictions that take into account revised estimates of bioaccumulation potential suggest that the substance has a low acute toxicity to aquatic organisms.

For this screening assessment, a very conservative exposure scenario was selected whereby an industrial operation (user of the pigment) discharges to the aquatic environment. The predicted environmental concentration in water was many orders of magnitude below predicted no-effect concentrations calculated for fish and daphnids.

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.

Conclusion

Based on the information available, Pigment Red 247:1 does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

The final 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 187 is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of a final Screening Assessment Report conducted on Pigment Red 187 pursuant to section 74 of the Act is annexed hereby; and

Whereas Pigment Red 187 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 187 at this time under section 77 of the Act.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of 2-Naphthalenecarboxamide, 4-[[5-[[[4-(aminocarbonyl)phenyl] amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-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, 4-[[5-[[[4-(aminocarbonyl)phenyl]amino] carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3hydroxy- (Pigment Red 187), Chemical Abstracts Service Registry No. 59487-23-9. 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 is believed to be in commerce in Canada.

The substance Pigment Red 187 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 (i.e. it did not meet the criteria of both being considered to present greatest or intermediate potential for exposure and having been classified by another national or international regulatory agency on the basis of carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity). Therefore, this assessment focuses on information relevant to the evaluation of ecological risks.

Pigment Red 187 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 the food and beverage sector. Its secondary use is as an inert ingredient in pesticides. The substance is not naturally produced in the environment. It is not reported to be manufactured in Canada; however, between 1 001 and 100 000 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. Assumptions and input parameters used in making these estimates are based on information obtained from a variety of sources including responses to regulatory surveys, Statistics Canada, manufacturers’ Web sites and technical databases. Estimates predict that as much as 4.1% and 2.5% of Pigment Red 187 may be released to water and soil, respectively. No releases are predicted to air. Pigment Red 187 presents very low experimental solubilities in water and octanol (< 50 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 187 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.

For this screening assessment, a very conservative exposure scenario was selected whereby an industrial operation (user of the pigment) discharges Pigment Red 187 into the aquatic environment. The predicted environmental concentration in water was many orders of magnitude below predicted no-effect concentrations calculated for fish, daphnids and algae.

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.

Conclusion

Based on the information available, Pigment Red 187 does not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas methyloxirane 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 final Screening Assessment Report conducted on methyloxirane pursuant to section 74 of the Act is annexed hereby; and

Whereas methyloxirane 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 methyloxirane be added to Schedule 1 to the Act;

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach documents

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Oxirane, methyl-

The Ministers of the Environment and of Health have conducted a screening assessment of Oxirane, methyl- (methyloxirane), Chemical Abstracts Service Registry No. 75-56-9, a substance identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. Methyloxirane was identified as a high priority as it was considered to pose greatest potential for exposure (GPE) to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity. While the substance did meet the ecological categorization criterion for persistence, it did not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of methyloxirane relates to human health aspects.

Methyloxirane was reported to be imported into Canada in 2006 in a quantity greater than 10 000 000 kg. It is used mainly as a monomer in polymer production of polyether polyols and to a lesser degree in the production of propylene glycol.

Population exposure to methyloxirane in Canada is expected to be predominantly in air, based on its potential releases to this medium and its high vapour pressure. Based on very limited information on levels in environmental media and the results of fugacity modelling, exposure in the general environment is expected to be low. However, exposure to methyloxirane may be elevated during use of consumer products containing the substance.

In light of weight of evidence based assessments by several international and national agencies, a critical effect for the characterization of risk to human health is carcinogenicity, based on the observation of nasal cavity tumours in rats and mice. Methyloxirane was also genotoxic in several in vitro and in vivo assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material. In addition, the upper-bounding estimate of exposure via inhalation during use of consumer products containing methyloxirane may approach or exceed the critical effect level for non-cancer effects in the nasal cavity.

On the basis of the carcinogenicity of methyloxirane, for which there may be a probability of harm at any level of exposure, as well as the potential inadequacy of the margin between estimated exposure from products and the critical effect level for non-cancer effects, it is concluded that methyloxirane is a substance that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of ecological hazard and reported releases of methyloxirane, it is concluded 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. Methyloxirane meets the criterion for persistence, but it does not meet the criterion for bioaccumulation potential 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.

Conclusion

Based on the information available, methyloxirane meets one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas ethyloxirane 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 final Screening Assessment Report conducted on ethyloxirane pursuant to section 74 of the Act is annexed hereby; and

Whereas ethyloxirane 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 ethyloxirane be added to Schedule 1 to the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Oxirane, ethyl-

The Ministers of the Environment and of Health have conducted a screening assessment of Oxirane, ethyl-, (ethyloxirane), Chemical Abstracts Service Registry No. 106-88-7, a substance identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. Ethyloxirane was identified as a high priority as it was considered to pose intermediate potential for exposure (IPE) to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity. While the substance did meet the ecological categorization criteria for persistence, it did not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. Therefore, the focus of this assessment of ethyloxirane relates to human health aspects.

Ethyloxirane was reported to be imported into Canada in 2006 in a total quantity in the range of 10 000–100 000 kg/yr. It is used principally as a stabilizer in industrial solvents that, in turn, are primarily used for vapour degreasing, as well as in ultrasonic and cleaning solvents.

Population exposure to ethyloxirane in Canada is expected to be predominantly in air, based on its potential releases to this medium and its high vapour pressure. Although no quantitative data on levels of ethyloxirane in environmental media are available, based on the results of fugacity modelling, exposure of the general population is expected to be very low. Consumer exposure is expected to be negligible, as the products in which ethyloxirane is present are used primarily in industrial and occupational settings.

Based principally on weight of evidence based assessments of international agencies, the critical effect for the characterization of risk to human health is carcinogenicity, based on the increased incidence of tumours of the respiratory system in rats exposed via inhalation. Ethyloxirane was also genotoxic in a range of in vitro assays and a limited number of in vivo assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct action with genetic material.

On the basis of the carcinogencity of ethyloxirane, for which there may be a probability of harm at any level of exposure, it is concluded that ethyloxirane is a substance that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of ecological hazard and reported releases of ethyloxirane, it is concluded 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. Ethyloxirane meets the criterion for persistence but it does not meet the criterion for bioaccumulation potential 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.

Conclusion

Based on the information available, ethyloxirane meets one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas TDI mixed isomers 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 final Screening Assessment Report conducted on TDI mixed isomers pursuant to section 74 of the Act is annexed hereby; and

Whereas TDI mixed isomers meet one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to recommend to Her Excellency the Governor in Council that TDI mixed isomers be added to Schedule 1 to the Act;

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

Whereas an assessment has been conducted pursuant to section 74 of the Canadian Environmental Protection Act, 1999 on TDI mixed isomers and that also covers the substances 2,4-TDI and 2,6-TDI; and

Whereas 2,4-TDI and 2,6-TDI meet one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Ministers of the Environment and of Health propose to recommend to Her Excellency the Governor in Council that 2,4-TDI and 2,6-TDI be added to Schedule 1 to the Act;

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for these substances.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of TDI mixed isomers, 2,4-TDI and 2,6-TDI

The Ministers of the Environment and of Health have conducted a screening assessment of mixed isomers of toluene diisocyanate (TDI), Chemical Abstracts Service Registry No. (CAS) 26471-62-5; Benzene, 2,4-diisocyanato-1-methyl- (2,4-TDI), CAS No. 584-84-9; and Benzene, 1,3-diisocyanato-2-methyl- (2,6-TDI), CAS No. 91-08-7. These substances were identified in the categorization of the Domestic Substances List as high priorities for action under the Ministerial Challenge. They were considered to pose the greatest potential for exposure to individuals in Canada (GPE) in the case of CAS No. 26471-62-5, or an intermediate potential for exposure to individuals in Canada (IPE) in the case of CAS No. 91-08-7 and CAS No. 584-84-9, and have been classified by other agencies on the basis of carcinogenicity. As these substances were determined not to meet the ecological categorization criteria for persistence, bioaccumulation potential, or inherent toxicity to aquatic organisms, the focus of this screening assessment relates to human health aspects.

The screening assessments for 2,4-TDI, 2,6-TDI and the mixed isomers have been combined because most toxicological data are available for the mixed isomers of TDI. The terms “TDI” and “toluene diisocyanate” in this assessment refer to either 2,4-TDI, 2,6-TDI, or the mixed isomers of TDI.

Toluene diisocyanate is an industrial chemical which was not manufactured by any company in Canada in a quantity above the reporting threshold of 100 kg in 2006 but which is imported into the country. In Canada, more than 85% of toluene diisocyanate was used in the manufacture of flexible polyurethane foam in 2006.

Industrial releases of TDI in Canada are mainly to air, and it is expected that most TDI released to air will remain in the vapour state and react chiefly with photolytically produced hydroxyl radicals, resulting in a half-life of less than two days. However, exposure to TDI may be elevated during use of consumer products containing the substance.

Based principally on a weight of evidence for carcinogenicity in assessments by several international and national agencies, the available human epidemiological data and the experimental animal data are equivocal and thus inadequate to determine the carcinogenic risk to TDI in humans, via the inhalation route. TDI is considered to be carcinogenic, since oral dosing in animals was associated with appearance of tumours at multiple sites. Mixed results have been obtained for TDI in in vivo and in vitro genotoxicity assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material.

The upper-bounding estimate of exposure via inhalation to the general population or during use of consumer products containing TDI may approach or exceed the critical effect levels for non-cancer effects in the respiratory system, including respiratory hypersensitivity. Additionally, TDI has been classified as a dermal and respiratory sensitizer by the European Union.

On the basis of the carcinogenicity of TDI mixed isomers, 2,4-TDI and 2,6-TDI, for which there may be a probability of harm at any level of exposure, as well as the potential inadequacy of the margins between estimated exposure to the general population or exposure from products and critical effect levels for non-cancer effects, it is concluded that these are substances that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of ecological hazard and reported releases of TDI mixed isomers, 2,4-TDI and 2,6-TDI, it is concluded that these substances are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends. Additionally, TDI mixed isomers, 2,4-TDI and 2,6-TDI do not meet criteria for persistence and bioaccumulation potential 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 and, where appropriate, the performance of potential control measures identified during the risk management phase.

Conclusion

Based on the information available, TDI mixed isomers, 2,4-TDI and 2,6-TDI meet one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

The final Screening Assessment Report as well as the proposed risk management approach document for these substances are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Whereas Naphthalene 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 final Screening Assessment Report conducted on Naphthalene pursuant to section 74 of the Act is annexed hereby; and

Whereas Naphthalene 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 Naphthalene be added to Schedule 1 to the Canadian Environmental Protection Act, 1999.

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of Naphthalene

The Ministers of the Environment and of Health have conducted a screening assessment of naphthalene, Chemical Abstracts Service Registry No. 91-20-3, a substance identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. Naphthalene was identified as a high priority as it was considered to pose greatest potential for exposure (GPE) to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity. While the substance did meet the ecological categorization criteria for inherent toxicity to aquatic organisms, it did not meet the criteria for persistence or bioaccumulation. Therefore, the focus of this assessment of naphthalene relates to human health aspects.

Based on a survey conducted under section 71 of CEPA 1999, in 2000, Canadian companies reported manufacturing more than 52 000 000 kg of naphthalene, and importing more than 150 000 000 kg into the country. Naphthalene has a wide variety of industrial uses and is also a component of a variety of consumer products.

Population exposure to naphthalene in Canada is expected to be predominantly via inhalation of indoor air, accounting for more than 95% of the total daily intake across age groups.

In light of weight of evidence based assessments by several international and national agencies, a critical effect for the characterization of risk to human health is carcinogenicity, based on the observation of respiratory tract tumours in rodents. Naphthalene was also genotoxic in some assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material. In addition, the upper-bounding concentration of naphthalene in indoor air may approach the critical effect level for non-cancer effects of the respiratory system.

On the basis of the carcinogencity of naphthalene, for which there may be a probability of harm at any level of exposure, as well as the potential inadequacy of the margin between the upper-bounding concentration of naphthalene in indoor air and the critical effect level for non-cancer effects, it is concluded that naphthalene 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.

It is concluded 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. Additionally, naphthalene does not meet criteria for persistence and bioaccumulation potential 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.

Conclusion

Based on the information available, naphthalene meets one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas a summary of the final Screening Assessment Report conducted on 1,2-benzenediol pursuant to paragraph 68(b) of the Canadian Environmental Protection Act, 1999 is annexed hereby; and

Whereas 1,2-benzenediol 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 1,2-benzenediol be added to Schedule 1 to the Act;

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of 1,2-Benzenediol

The Ministers of the Environment and of Health have conducted a screening assessment of 1,2-benzenediol, Chemical Abstracts Service Registry No. 120-80-9, a substance identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. 1,2-Benzenediol was identified as a high priority as it was considered to pose an intermediate potential for exposure (IPE) to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity. Since the substance did not meet the ecological categorization criteria for persistence, bioaccumulation or inherent toxicity to aquatic organisms, the focus of this assessment of 1,2-benzenediol relates to human health aspects.

Under information reported pursuant to section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the total quantity of 1,2-benzenediol that was manufactured in Canada or imported into the country in 2006 ranged between 1 000 000 and 10 000 000 kg. The majority of 1,2-benzenediol manufactured in Canada is generated as a by-product of kraft pulp production; however, it is destroyed elsewhere in the process through combustion or removed during effluent treatment. 1,2-Benzenediol is used as a component in photographic developer and in various applications (e.g. laboratory reagent, antioxidant in electroplating baths) that would not result in exposure to the general population. 1,2-Benzenediol is found to occur naturally, including in various food items.

The predominant source of general population exposure to 1,2-benzenediol is expected to be as a result of its naturally occurring presence in food and beverages. Contributions to total exposure from the other media (ambient and indoor air, water and soil) are considered negligible in comparison. There may also be inhalation and dermal exposure to 1,2-benzenediol from its presence in photographic developer.

In light of weight of evidence based assessments by other agencies, a critical effect for the characterization of risk to human health is carcinogenicity, based on observation of tumours, including tumours in the glandular stomach in rats chronically exposed to the substance. 1,2-Benzenediol was genotoxic in several in vitro and in vivo assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material.

On the basis of the carcinogenicity of 1,2-benzenediol, for which there may be a probability of harm at any level of exposure, it is concluded that 1,2-benzenediol is a substance that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of ecological hazard and reported releases of 1,2-benzenediol, it is concluded 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. Additionally, 1,2-benzendiol does not meet criteria for persistence and bioaccumulation potential 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.

Conclusion

Based on the information available, 1,2-benzenediol meets one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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

Whereas 1,4-benzenediol 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 final Screening Assessment Report conducted on 1,4-benzenediol pursuant to section 74 of the Act is annexed hereby; and

Whereas 1,4-benzenediol 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 1,4-benzenediol be added to Schedule 1 to the Act.

Notice is furthermore given that the Ministers of the Environment and of Health have released a proposed risk management approach document, for a public comment period of 60 days, to continue discussions with stakeholders regarding the risk management actions for this substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the risk management approach document. More information regarding the proposed risk management approach 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.

JOHN BAIRD
Minister of the Environment
TONY CLEMENT
Minister of Health

ANNEX

Summary of the Screening Assessment Report of 1,4-Benzenediol

The Ministers of the Environment and of Health have conducted a screening assessment of 1,4-benzenediol, Chemical Abstracts Service Registry No. 123-31-9, a substance identified in the categorization of the Domestic Substances List as a high priority for action under the Ministerial Challenge. It was identified as such because it was considered to pose greatest potential for exposure (GPE) to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity. While the substance did meet the ecological categorization criteria for inherent toxicity to aquatic organisms, it did not meet the criteria for persistence or bioaccumulation. Therefore, the focus of this assessment of 1,4-benzenediol relates to human health aspects.

Based on information reported pursuant to section 71 of the Canadian Environmental Protection Act, 1999, the total quantity of 1,4-benzenediol imported into Canada in 2006 was between 100 000 kg and 1 000 000 kg. Uses of 1,4-benzenediol in Canada include the following: as a polymerization inhibitor in unsaturated polyester and methylmethacrylate resin monomers; as a stabilizer in colourants and various types of industrial and consumer adhesives, thread lockers and thread sealants; as an additive to heat shrink tubing, restorative paste, bonding tape, film tape and liquid bandages; as a performance additive in sheetfed printing and heatset inks; and as a reducing agent in photographic developer. 1,4-Benzenediol occurs naturally, including in various food items.

The predominant source of general population exposure to 1,4-benzenediol is expected to be as a result of its natural presence, or the presence of the glucose conjugate, 4-Hydroxyphenyl-β-D-glucopyranoside (arbutin), in various food and beverages. Contributions to total exposure from the other media (ambient and indoor air, water and soil) are considered negligible in comparison.

There may also be dermal exposure to 1,4-benzenediol in consumer products such as photographic developers, adhesives, certain cosmetic products such as hair dyes, and various authorized skin lightening creams.

In light of the weight of evidence based assessment of the European Commission, the critical effect for the characterization of risk to human health is carcinogenicity, based on the observation of tumours, including kidney tumours, in rats and mice chronically exposed to the substance (oral exposure). 1,4-Benzenediol was also genotoxic in several in vitro and in vivo assays. Therefore, although the mode of induction of tumours has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals resulted from direct interaction with genetic material.

On the basis of the carcinogenicity of 1,4-benzenediol, for which there may be a probability of harm at any level of exposure, it is concluded that 1,4-benzenediol is a substance that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of ecological hazard and reported releases of 1,4-benzenediol, it is concluded 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. Additionally, 1,4-benzenediol does not meet criteria for persistence and bioaccumulation potential 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.

Conclusion

Based on the information available, 1,4-benzenediol meets one or more of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999.

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