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Vol. 145, No. 27 — July 2, 2011

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of this Act applies to 53 substances

Whereas the substances set out in Annex 1 to this notice are specified on the Domestic Substances List;

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of these substances, under section 68 or 74 of the Canadian Environmental Protection Act, 1999 and have released a summary of the results on March 26, 2011, in the Canada Gazette, Part I, for a 60-day public comment period;

Whereas the Ministers are satisfied that those substances are not being manufactured in or imported into Canada by any person in a quantity of more than 100 kg in any one calendar year;

And whereas the Ministers suspect that a significant new activity in relation to any of those substances may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 by having a harmful effect on the environment or by constituting a danger in Canada to human life or health,

Therefore, notice is hereby given that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to any new activity relating to the substances in accordance with Annex 2.

Public comment period

Any person may, within 60 days of publication of this notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent by mail to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).

The screening assessment report for those substances may be obtained from the Government of Canada’s Chemical Substances Web site at www.chemicalsubstanceschimiques.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
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

ANNEX 1

The substances to which the present notice applies are

1. Ethanamine, N-ethyl-N-nitroso- (Chemical Abstracts Service [CAS] Registry No. 55-18-5);

2. Hydrazine, phenyl-, monohydrochloride (CAS Registry No. 59-88-1);

3. Acetamide (CAS Registry No. 60-35-5);

4. Methanesulfonic acid, ethyl ester (CAS Registry No. 62-50-0);

5. Ethanethioamide (CAS Registry No. 62-55-5);

6. Methanesulfonic acid, methyl ester- (CAS Registry No. 66-27-3);

7. Methane, tribromo- (CAS Registry No. 75-25-2);

8. Ethane, pentachloro- (CAS Registry No. 76-01-7);

9. 1-Propene, 2,3-dichloro- (CAS Registry No. 78-88-6);

10. Ethane, 1,1,2-trichloro- CAS Registry No. 79-00-5);

11. Acetamide, N-methyl- CAS Registry No. 79-16-3);

12. 1,3-Benzodioxole, 5-propyl- (CAS Registry No. 94-58-6);

13. Oxirane, phenyl- (CAS Registry No. 96-09-3);

14. Propane, 1,2,3-trichloro- (CAS Registry No. 96-18-4);

15. Hydrazine, phenyl- (CAS Registry No. 100-63-0);

16. Benzenamine, 4,4′-methylenebis[N,N-dimethyl- (CAS Registry No. 101-61-1);

17. 7-Oxabicyclo[4.1.0]heptane, 3-oxiranyl- (CAS Registry No. 106-87-6);

18. 1,3,5-Trioxane (CAS Registry No. 110-88-3);

19. Bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid, 1,4,5,6,7,7-hexachloro- (CAS Registry No. 115-28-6);

20. Ethene, tetrafluoro- (CAS Registry No. 116-14-3);

21. Oxirane, (phenoxymethyl)- (CAS Registry No. 122-60-1);

22. Formamide, N-methyl- (CAS Registry No. 123-39-7);

23. 2-Butenal, (E)- (CAS Registry No. 123-73-9);

24. 1,2-Benzenedicarboxylic acid, dipentyl ester (CAS Registry No. 131-18-0);

25. Phenol, pentachloro-, sodium salt (CAS Registry No. 131-52-2);

26. Benzenamine, N-hydroxy-N-nitroso-, ammonium salt (CAS Registry No. 135-20-6);

27. 1-Triazene, 1,3-diphenyl- (CAS Registry No. 136-35-6);

28. 4(1H)-Pyrimidinone, 2,3-dihydro-2-thioxo- (CAS Registry No. 141-90-2);

29. 2-Propenoic acid, 3-(3,4-dihydroxyphenyl)- (CAS Registry No. 331-39-5);

30. Benzenamine, 4,4′-carbonimidoylbis[N,N-dimethyl- (CAS Registry No. 492-80-8);

31. Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, monohydrochloride (CAS Registry No. 569-61-9);

32. 2-Hexanone- (CAS Registry No. 591-78-6);

33. Ethene, bromo- (CAS Registry No. 593-60-2);

34. Benzene, 2-methyl-1,3-dinitro- (CAS Registry No. 606-20-2);

35. 1,2-Benzenediamine, dihydrochloride (CAS Registry No. 615-28-1);

36. 1,3-Benzenediamine, 2-methyl- (CAS Registry No. 823-40-5);

37. 1,2-Oxathiolane, 2,2-dioxide- (CAS Registry No. 1120-71-4);

38. Benzenemethanaminium, N-[4-[[4-(dimethylamino)phenyl] [4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium salt- (CAS Registry No. 1694-09-3);

39. 1,3-Propanediol, 2,2-bis(bromomethyl)- (CAS Registry No. 3296-90-0);

40. 2-Butenal (CAS Registry No. 4170-30-3);

41. Hydrazine, sulfate (1:1) (CAS Registry No. 10034-93-2);

42. Hydroxylamine, sulfate (1:1) (salt) (CAS Registry No. 10046-00-1);

43. Nickel carbonyl (Ni(CO)4), (T-4)- (CAS Registry No. 13463-39-3);

44. Boric acid (H3BO3), sodium salt (CAS Registry No. 13840-56-7);

45. Urea, N′-(3-chloro-4-methylphenyl)-N,N-dimethyl- (CAS Registry No. 15545-48-9);

46. Carbamic acid, [1,2-phenylenebis(iminocarbonothioyl)]bis-, dimethyl ester- (CAS Registry No. 23564-05-8);

47. Morpholine, 2,6-dimethyl-4-tridecyl- (CAS Registry No. 24602-86-6);

48. Benzene, methyldinitro- (CAS Registry No. 25321-14-6);

49. 1,3-Benzenediamine, ar-methyl- (CAS Registry No. 25376-45-8);

50. Oxirane, [(methylphenoxy)methyl]- (CAS Registry No. 26447-14-3);

51. 1,3-Benzenediamine, 4-methoxy-, sulfate (1:1) (CAS Registry No. 39156-41-7);

52. 1,4-Dithiin, 2,3-dihydro-5,6-dimethyl-, 1,1,4,4-tetraoxide (CAS Registry No. 55290-64-7); and

53. Carbamic acid, [(2-methylpropoxy)thioxomethyl]-, ethyl ester- (CAS Registry No. 103122-66-3).

ANNEX 2

The following CAS Registry Numbers are proposed to be removed from Part 1 of the Domestic Substances List and added to column 1 of Part 2 of this list with, in column 2 of this part and in relation to each number being added, the description of significant new activities that follows.

1. 55-18-5 S′

2. 59-88-1 S′

3. 60-35-5 S′

4. 62-50-0 S′

5. 62-55-5 S′

6. 66-27-3 S′

7. 75-25-2 S′

8. 76-01-7 S′

9. 78-88-6 S′

10. 79-00-5 S′

11. 79-16-3 S′

12. 94-58-6 S′

13. 96-09-3 S′

14. 96-18-4 S′

15. 100-63-0 S′

16. 101-61-1 S′

17. 106-87-6 S′

18. 110-88-3 S′

19. 115-28-6 S′

20. 116-14-3 S′

21. 122-60-1 S′

22. 123-39-7 S′

23. 123-73-9 S′

24. 131-18-0 S′

25. 131-52-2 S′

26. 135-20-6 S′

27. 136-35-6 S′

28. 141-90-2 S′

29. 331-39-5 S′

30. 492-80-8 S′

31. 569-61-9 S′

32. 591-78-6 S′

33. 593-60-2 S′

34. 606-20-2 S′

35. 615-28-1 S′

36. 823-40-5 S′

37. 1120-71-4 S′

38. 1694-09-3 S′

39. 3296-90-0 S′

40. 4170-30-3 S′

41. 10034-93-2 S′

42. 10046-00-1 S′

43. 13463-39-3 S′

44. 13840-56-7 S′

45. 15545-48-9 S′

46. 23564-05-8 S′

47. 24602-86-6 S′

48. 25321-14-6 S′

49. 25376-45-8 S′

50. 26447-14-3 S′

51. 39156-41-7 S′

52. 55290-64-7 S′

53. 103122-66-3 S′

Significant new activities

1. A significant new activity is any activity involving, in any one calendar year, more than 100 kg of any substance listed above.

2. For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:

  • (a) a description of the proposed new activity in relation to the substance; and
  • (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).

3. The above information will be assessed within 90 days after the day it is received by the Minister.

[27-1-o]

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to amend the Domestic Substances List under subsection 112(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 106(3) of that Act applies to three substances

Whereas the three substances set out in Annex 1 to this notice are specified on the Domestic Substances List;

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances, under section 74 of the Canadian Environmental Protection Act, 1999 and have released a summary of the results of this process on July 2, 2011, in the Canada Gazette, Part I, for a 60-day public comment period;

Whereas the Ministers are satisfied that those substances, in any one calendar year, are not being manufactured in or imported into Canada for commercial or consumer uses by any person;

And whereas the Ministers suspect that a significant new activity in relation to any of those substances may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,

Therefore, notice is hereby given that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 106(3) of that Act applies to the three substances set out in Annex 1 to this notice in accordance with Annex 2.

Public comment period

Any person may, within 60 days of publication of this notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent by mail to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), or substances@ec.gc.ca (email).

The screening assessment report for these substances may be obtained from the Government of Canada’s Chemical Substances Web site at www.chemicalsubstanceschimiques.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.

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

ANNEX 1

The organisms to which the present notice applies are

1. Pseudomonas aeruginosa (American Type Culture Collection [ATCC]31480);
2. Pseudomonas aeruginosa ATCC700370; and
3. Pseudomonas aeruginosa ATCC700371.

ANNEX 2

1. Part 5 of the Domestic Substances List is proposed to be amended by deleting the following:

ATCC31480
ATCC700370
ATCC700371

2. Part 6 of the List is proposed to be amended by adding the following in numerical order:

Column 1

Substance

Column 2
Significant New Activity for which living organism is subject to subsection 112(3) of the Act

ATCC31480 S′

  1. Any activity involving the organism Pseudomonas aeruginosa ATCC31480.
  2. Despite item 1, the use of the organism as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms) with a volume of less than 250 L present at any one time is not a new activity.
  3. For each significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the first organism is manufactured, imported or used:
    • (a) a description of the proposed new activity in relation to the organism;
    • (b) subject to paragraphs (c) to (e), the information specified in Schedule 1 of the New Substances Notification Regulations (Organisms);
    • (c) when the organism is to be used inside a contained facility as defined in subsection 1(1) of those Regulations, the information specified in Schedule 2 to those Regulations;
    • (d) when the organism is to be used in an experimental field study as defined in subsection 1(1) of those Regulations, the information specified in Schedule 3 to those Regulations; and
    • (e) when the organism is to be used at the site from which it was isolated, the information specified in Schedule 4 to those Regulations.
  4. The above information will be assessed within 120 days after the day on which it is received by the Minister.

ATCC700370 S′

  1. Any activity involving the organism Pseudomonas aeruginosa ATCC700370.
  2. Despite item 1, the use of the organism as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms) with a volume of less than 250 L present at any one time is not a new activity.
  3. For each significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the first organism is manufactured, imported or used:
    • (a) a description of the proposed new activity in relation to the organism;
    • (b) subject to paragraphs (c) to (e), the information specified in Schedule 1 of the New Substances Notification Regulations (Organisms);
    • (c) when the organism is to be used inside a contained facility as defined in subsection 1(1) of those Regulations, the information specified in Schedule 2 to those Regulations;
    • (d) when the organism is to be used in an experimental field study as defined in subsection 1(1) of those Regulations, the information specified in Schedule 3 to those Regulations; and
    • (e) when the organism is to be used at the site from which it was isolated, the information specified in Schedule 4 to those Regulations.
  4. The above information will be assessed within 120 days after the day on which it is received by the Minister.

ATCC700371 S′

  1. Any activity involving the organism Pseudomonas aeruginosa ATCC700371.
  2. Despite item 1, the use of the organism as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms) with a volume of less than 250 L present at any one time is not a new activity.
  3. For each significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the first organism is manufactured, imported or used:
    • (a) a description of the proposed new activity in relation to the organism;
    • (b) subject to paragraphs (c) to (e), the information specified in Schedule 1 of the New Substances Notification Regulations (Organisms);
    • (c) when the organism is to be used inside a contained facility as defined in subsection 1(1) of those Regulations, the information specified in Schedule 2 to those Regulations;
    • (d) when the organism is to be used in an experimental field study as defined in subsection 1(1) of those Regulations, the information specified in Schedule 3 to those Regulations; and
    • (e) when the organism is to be used at the site from which it was isolated, the information specified in Schedule 4 to those Regulations.
  4. The above information will be assessed within 120 days after the day on which it is received by the Minister.

COMING INTO FORCE

3. The Order would come into force on the day on which it is registered.

[27-1-o]

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of a living organism— Pseudomonas aeruginosa strains ATCC 31480, ATCC 700370 and ATCC 700371— specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas P. aeruginosa strains ATCC 31480, ATCC 700370 and ATCC 700371 are micro-organisms on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment conducted on these micro-organisms, pursuant to section 74 of the Act, is annexed hereby;

Whereas the Ministers of the Environment and of Health have identified no commercial or consumer activities for these micro-organisms;

Whereas it is proposed to conclude that these micro-organisms 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 112(3) of the Act, to indicate that subsection 106(3) thereof applies with respect to these micro-organisms,

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

Public comment period

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

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

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

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the draft Screening Assessment report of P. aeruginosa strains ATCC 31480, ATCC 700370 and ATCC 700371

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of Environment and of Health have conducted a screening assessment on three strains of Pseudomonas aeruginosa (ATCC strains 31480, 700370 and 700371). These strains are listed on the Domestic Substances List (DSL) thus indicating that they were in commerce in Canada between 1984 and 1986.

The species Pseudomonas aeruginosa is generally considered a ubiquitous bacterium, occurring naturally in many environmental media; P. aeruginosa is probably one of the most widespread of all bacterial species. It has the ability to adapt to and thrive in many ecological niches especially those that are moist. The species possesses characteristics that allow for multiple potential uses in various industrial and commercial sectors. These include waste degradation (particularly in oil refineries), textile, pulp and paper, mining and explosives industries, as well as in commercial and household drain cleaners and degreasers, septic tank additives and general cleaning products and odour control products.

Information from the scientific literature indicates that P. aeruginosa is an opportunistic animal pathogen, meaning that it is an organism that can, under certain conditions, infect some but not all individuals of a susceptible host species. There is no evidence in the scientific literature to suggest any adverse ecological effects at the population level. P. aeruginosa is recognized as a Risk Group 2 pathogen by the Canadian Food Inspection Agency (Animal Pathogen Import Program). Generally, Risk Group 2 pathogens are any pathogens that can cause disease but, under normal circumstances, are unlikely to be a serious risk to organisms in the environment. If needed, effective treatment and preventive measures are available, and the risk of spread is limited.

Information from the scientific literature indicates that this micro-organism has pathogenic potential in both otherwise healthy and immunocompromised humans. P. aeruginosa is recognized by the Public Health Agency of Canada as a Risk Group 2 human pathogen. It has the ability to spread and acquire antibiotic resistance genes which may compromise the effectiveness of antibiotics that are currently used for the treatment of P. aeruginosa infections. P. aeruginosa produces a wide variety of extracellular enzymes and toxins that are important factors for its pathogenicity in susceptible humans.

To establish whether living organisms on the DSL continue to be manufactured in or imported into Canada, a notice was issued pursuant to paragraph 71(1)(a) of CEPA 1999. There were no reports of industrial activity (import or manufacture) with respect to these substances in Canada for the specified reporting year of 2008. These results indicate that in 2008, the three DSL-listed strains of P. aeruginosa (31480, 700370 and 700371) were not imported or manufactured and therefore the likelihood of exposure to these substances in Canada resulting from commercial activity is low.

Proposed conclusion

It is proposed that the above substances are currently not entering or likely to enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or constitute a danger to the environment on which life depends or that constitute a danger in Canada to human life or health. Therefore, it is proposed that these substances do not meet any of the criteria as set out in section 64 of CEPA 1999.

However, should exposure increase through new activities, there is a potential risk to human health and the environment based on the pathogenicity and toxicity of P. aeruginosa to susceptible humans and non-human species. Therefore, there is concern that new activities for the above substances which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria as set out in section 64 of the Act. Therefore, it is recommended that the above substances be subject to the significant new activity provisions specified under subsection 106(3) of the Act, to ensure that any new manufacture, import or use of these substances will undergo ecological and human health assessments as specified in section 108 of the Act, prior to the substances being considered for introduction into Canada.

The draft Screening Assessment for these micro-organisms is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[27-1-o]

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of 53 substances specified on the Domestic Substances List (subsection 77(1) and paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas the 15 substances set out in Annex 1 to this notice are substances on the Domestic Substances List that were identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft Screening Assessment on 53 substances set out in Annex 2 to this notice (the substances) conducted pursuant to paragraphs 68(b) and (c) and section 74 of the Canadian Environmental Protection Act, 1999, is annexed hereby;

Whereas it is proposed to conclude that the substances do not meet any of the criteria set out in section 64 of the Act by having a harmful effect on the environment or by constituting a danger in Canada to human life or health; and

Whereas that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 87(3) of the Act to indicate new activities relating to the substance are subject to subsection 81(3),

Therefore, notice is hereby given that the Ministers of the Environment and of Health propose to take no further action on these substances 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 Minister proposes to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances. gc.ca). All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Science and Risk Assessment Directorate, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax) or substances@ec.gc.ca (email).

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

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

KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX 1

Substances identified under subsection 73(1) of CEPA 1999

Chemical Abstracts Service (CAS1) Registry No.

Substance name

75-25-2

Methane, tribromo-

76-01-7

Ethane, pentachloro-

96-09-3

Oxirane, phenyl-

96-18-4

Propane, 1,2,3-trichloro-

101-61-1

Benzenamine, 4,4′-methylenebis[N,N-dimethyl-

115-28-6

Bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid, 1,4,5,6,7,7-hexachloro-

116-14-3

Ethene, tetrafluoro-

131-52-2

Phenol, pentachloro-, sodium salt

606-20-2

Benzene, 2-methyl-1,3-dinitro-

1694-09-3

Benzenemethanaminium, N-[4-[[4-(dimethylamino) phenyl][4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium salt

3296-90-0

1,3-Propanediol, 2,2-bis(bromomethyl)-

10034-93-2

Hydrazine, sulfate (1:1)

10046-00-1

Hydroxylamine, sulfate (1:1) (salt)

13463-39-3

Nickel carbonyl (Ni(CO)4), (T-4)-

24602-86-6

Morpholine, 2,6-dimethyl-4-tridecyl-

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

ANNEX 2

Summary of the screening assessment report on 53 substances (Substances identified under subsection 73(1) and conducted pursuant to paragraphs 68(b) and (c), and section 74 of CEPA 1999)

Chemical Abstracts Service (CAS1) Registry No.

Substance name

55-18-5

Ethanamine, N-ethyl-N-nitroso-

59-88-1

Hydrazine, phenyl-, monohydrochloride

60-35-5

Acetamide

62-50-0

Methanesulfonic acid, ethyl ester

62-55-5

Ethanethioamide

66-27-3

Methanesulfonic acid, methyl ester-

75-25-2

Methane, tribromo-

76-01-7

Ethane, pentachloro-

78-88-6

1-Propene, 2,3-dichloro-

79-00-5

Ethane, 1,1,2-trichloro-

79-16-3

Acetamide, N-methyl-

94-58-6

1,3-Benzodioxole, 5-propyl-

96-09-3

Oxirane, phenyl-

96-18-4

Propane, 1,2,3-trichloro-

100-63-0

Hydrazine, phenyl-

101-61-1

Benzenamine, 4,4′-methylenebis[N,N-dimethyl-

106-87-6

7-Oxabicyclo[4.1.0]heptane, 3-oxiranyl-

110-88-3

1,3,5-Trioxane

115-28-6

Bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid, 1,4,5,6,7,7-hexachloro-

116-14-3

Ethene, tetrafluoro-

122-60-1

Oxirane, (phenoxymethyl)-

123-39-7

Formamide, N-methyl-

123-73-9

2-Butenal, (E)-

131-18-0

1,2-Benzenedicarboxylic acid, dipentyl ester

131-52-2

Phenol, pentachloro-, sodium salt

135-20-6

Benzenamine, N-hydroxy-N-nitroso-, ammonium salt

136-35-6

1-Triazene, 1,3-diphenyl-

141-90-2

4(1H)-Pyrimidinone, 2,3-dihydro-2-thioxo-

331-39-5

2-Propenoic acid, 3-(3,4-dihydroxyphenyl)-

492-80-8

Benzenamine, 4,4′-carbonimidoylbis[N,N-dimethyl-

569-61-9

Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, monohydrochloride

591-78-6

2-Hexanone

593-60-2

Ethene, bromo-

606-20-2

Benzene, 2-methyl-1,3-dinitro-

615-28-1

1,2-Benzenediamine, dihydrochloride

823-40-5

1,3-Benzenediamine, 2-methyl-

1120-71-4

1,2-Oxathiolane, 2,2-dioxide

1694-09-3

Benzenemethanaminium, N-[4-[[4-(dimethylamino)phenyl][4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-3-sulfo-, hydroxide, inner salt, sodium salt-

3296-90-0

1,3-Propanediol, 2,2-bis(bromomethyl)-

4170-30-3

2-Butenal

10034-93-2

Hydrazine, sulfate (1:1)

10046-00-1

Hydroxylamine, sulfate (1:1) (salt)

13463-39-3

Nickel carbonyl (Ni(CO)4), (T-4)-

13840-56-7

Boric acid (H3BO3), sodium salt

15545-48-9

Urea, N′-(3-chloro-4-methylphenyl)-N,N-dimethyl-

23564-05-8

Carbamic acid, [1,2-phenylenebis(iminocarbonothioyl)]bis-, dimethyl ester

24602-86-6

Morpholine, 2,6-dimethyl-4-tridecyl-

25321-14-6

Benzene, methyldinitro-

25376-45-8

1,3-Benzenediamine, ar-methyl-

26447-14-3

Oxirane, [(methylphenoxy)methyl

39156-41-7

1,3-Benzenediamine, 4-methoxy-, sulfate (1:1)

55290-64-7

1,4-Dithiin, 2,3-dihydro-5,6-dimethyl-, 1,1,4,4-tetraoxide

103122-66-3

Carbamic acid, [(2-methylpropoxy)thioxomethyl]-, ethyl ester

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

Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of the 53 substances listed above under sections 68 and 74. The substances included in this assessment were identified as priorities because they had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Fifteen substances were also determined to meet categorization criteria for persistence and/or bioaccumulation, and inherent toxicity (PBiT) to human or non-human organisms, under subsection 73(1) of CEPA 1999.

To establish whether certain high hazard substances were currently being manufactured in or imported into Canada, a survey was conducted by issuing a Notice with respect to selected substances identified as priority for action pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999. The notice was published in Part I of the Canada Gazette on March 4, 2006. An additional survey was conducted by issuing a Notice with respect to certain inanimate substances (chemicals) on the Domestic Substances List pursuant to paragraph 71(1)(b) of CEPA 1999. The notice was published in Part I of the Canada Gazette on October 3, 2009. The two surveys revealed no reports of industrial activities (import or manufacture) with respect to these substances above the reporting threshold of 100 kg per year for the specified reporting years. These substances are hence deemed not in commerce in Canada at the threshold of 100 kg for the specific reporting year. Additional entry characterization was conducted to identify direct exposure potential to the general population in Canada. No information was found on current uses or releases of these substances in Canada and therefore the likelihood of exposure to these substances in Canada resulting from commercial activity is low and hence the potential risks to human health or the environment are considered to be low.

Given the lack of any significant commercial activity for these substances, no further collection or analysis relevant to the persistence, bioaccumulation and toxicological effects of these substances, beyond what was done for categorization, has been conducted. Therefore, the decisions on human health hazard potential and persistence, bioaccumulation and aquatic toxicity properties made during categorization remain unchanged.

Proposed conclusion

Based on available information, and until new information is received indicating that these 53 substances are entering, or may enter the environment, from commercial activity or from other sources, it is proposed to conclude that these substances are currently not entering or likely to enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or constitute or may constitute a danger to the environment on which life depends or that constitute a danger in Canada to human life or health. Therefore, it is proposed to conclude that they do not meet any of the criteria as set out in section 64 of CEPA 1999.

As substances listed on the DSL, import and manufacture of these substances in Canada are not currently subject to notification under subsection 81(1). Given their potential high hazard for human health, there is concern that new activities for the above 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 to amend the DSL pursuant to subsection 87(3) of CEPA 1999 to indicate that the above substances are 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 assessments as specified in section 83 of the Act, prior to the substances being considered for introduction into Canada. In addition and where relevant, research and monitoring will support verification of assumptions used during this screening assessment.

[27-1-o]

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of Naphthalene, chloro derivatives, CAS (see footnote *) No. 70776-03-3 — substances specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Naphthalene, chloro derivatives are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas “Naphthalene, chloro derivatives” describes variable chemical mixture that contain chlorinated naphthalenes;

Whereas a summary of the Ecological Screening Assessment conducted on chlorinated naphthalenes pursuant to section 74 of the Act is annexed hereby;

Whereas a Human Health Screening Assessment will be conducted on chlorinated naphthalenes pursuant to section 74 of the Act, at a later date;

Whereas polychlorinated naphthalenes, i.e. chlorinated naphthalenes that contain more than one chlorine atom, meet one or more of the criteria set out in section 64 of the Act; and

Whereas the Minister of the Environment and the Minister of Health are satisfied that polychlorinated naphthalenes meet the criteria set out in subsection 77(4) of the Act since they are persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations, their presence in the environment results primarily from human activity and they are not naturally occurring radionuclides or naturally occurring inorganic substances,

Therefore, notice is hereby given that the Minister of the Environment and the Minister of Health intend to recommend to His Excellency the Governor in Council that polychlorinated naphthalenes, that contain more than one chlorine atom, be added to Schedule 1 to the Act.

Notice is further given that the Minister of the Environment and the Minister of Health propose risk management measures to achieve the objective of virtually eliminating releases of polychlorinated naphthalenes.

Notice is furthermore given that the Ministers of the Environment and of Health are releasing a risk management approach document for polychlorinated naphthalenes on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca) to continue discussions with stakeholders on the manner in which the Ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the 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, Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).

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

PETER KENT
Minister of the Environment
LEONA AGLUKKAQ
Minister of Health

ANNEX

Summary of the Draft Ecological Screening Assessment Report of Chlorinated Naphthalenes

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment has conducted an ecological screening assessment of chlorinated naphthalenes. “Naphthalene, chloro derivatives”, Chemical Abstracts Service Registry No. 70776-03-3, was identified as meeting the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms. “Naphthalene, chloro derivatives” is a variable chemical mixture that covers the chemical class of chlorinated naphthalenes.

Chlorinated naphthalenes were 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.

Chlorinated naphthalenes (CNs) have the molecular formula C10H8-nCln (n = 1–8). There are 75 possible chlorinated naphthalenes in eight homologue groups, based on the number of chlorine atoms in the molecule. These homologue groups are referred to using the prefixes mono- to octa- (e.g. mono-CNs, di-CNs). The number and, to a lesser extent, the positions of the chlorine atoms within the CN molecule are the key determinants of the physical and chemical properties of the CN congeners.

Key physical and chemical properties are useful when predicting the environmental fate of CNs. The values for water solubility, vapour pressure and the Henry’s law constant tend to decrease when progressing from mono- to octa-CNs, while the values for log Kow, melting point and boiling point tend to increase when progressing from mono- to octa-CNs.

Sources of CNs in the environment are mainly anthropogenic. Beginning around 1910, mono- to octa-CNs were produced commercially for a variety of uses. Chlorinated naphthalenes were likely never manufactured in Canada but they were imported from manufacturers in the United States. Although CNs are not currently in commercial use in Canada, they are likely to be produced unintentionally as a by-product of some industrial processes involving chlorine, especially in the presence of heat, such as waste incineration, cement and magnesium production, and the refining of metals such as aluminium. Releases resulting from some of these processes have not been well characterized. Other sources of CNs in the environment include products containing CNs disposed of in landfill sites and old industrial sites where CNs were used. There are reports of CNs being released into the atmosphere from the domestic combustion of wood. A possible non-anthropogenic (i.e. natural) source of CNs is the combustion of wood during forest fires.

Fugacity modelling has been used to predict which environmental compartments CNs are most likely to be found in. Chlorinated naphthalenes tend to remain in air or partition to soil when released only into air. Chlorinated naphthalenes tend to remain in water or partition to sediments when released only to water.

Chlorinated naphthalenes have been detected in Canada, specifically, in: Arctic and urban air, Lake Ontario water, fish and birds from the Great Lakes and environs, seals and whales from the Canadian Arctic, and Vancouver Island marmots. Much more data on CN levels in environmental media, including sediments and soils, are available for the United States and Europe.

Di- through octa-CNs are persistent in air. The potential for long-range transport has been estimated to be moderate for di-CNs and high for tri- through octa-CNs, indicating that some CNs may be subject to atmospheric transport to remote regions such as the Arctic. In addition, di- through octa-CNs are predicted to be persistent in water, and tri- through hepta-CNs are persistent in both sediments and soil. Based on the weight of evidence, including, in particular, measured log Kow values for di- to octa-CNs, the measured bioconcentration values for di- to penta-CNs in fish, measured biomagnification factors for tetra- to hepta-CNs, the high dietary uptake efficiencies of hexa- to octa-CNs in northern pike and the very slow elimination of hexa-CNs from rats, it is concluded that di- to octa-CNs are also bioaccumulative.

The available empirical and modelled aquatic toxicity data for CNs indicate that di-, tri-, tetra- and penta-CNs may be harmful to aquatic organisms at relatively low concentrations (below 1 mg/L for acute tests, and 0.1 mg/L for chronic tests). Hexa-, hepta- and octa-CNs were found to cause harmful effects in mammals (particularly cattle) after short term exposure at relatively low doses — as low as 0.69 mg/kg body weight per day.

Evidence that a substance is highly persistent and bioaccumulative, as defined in the Persistence and Bioaccumulation Regulations under the Canadian Environmental Protection Act, 1999, when taken together with potential for environmental release or formation and potential for toxicity in organisms, provides a significant indication that the substance may be entering the environment under conditions that may have harmful long-term ecological effects. Substances that are persistent remain in the environment for a long time after being released, increasing the potential magnitude and duration of exposure. Substances that have long half-lives in air and water and partition into them in significant proportions have the potential to cause widespread contamination. Releases of small amounts of bioaccumulative substances may lead to high internal concentrations in exposed organisms. Highly bioaccumulative and persistent substances are of special concern, since they may biomagnify in food webs, resulting in very high internal exposures, especially for top predators.

Based on the lines of evidence presented above, particularly the evidence for persistence, bioaccumulation and potential to cause harm at low exposure levels, and taking into account the limitations of existing quantitative risk estimation methods when applied to such substances, and recognizing that although CNs are no longer in commercial use in Canada they continue to enter the Canadian environment from unintentional production as well as through transboundary movement of air, it is concluded that releases of di- through octa-CNs have the potential to cause environmental harm in Canada.

Therefore, it is concluded that di- through octa-CNs are entering the environment in quantities or concentrations, or under conditions that have or may have immediate or long-term harmful effects on the environment or its biological diversity.

In addition and where relevant, research and monitoring will support verification of assumptions used during the screening assessment and, where appropriate, the performance of control measures identified during the risk management phase.

Conclusion

Based on the information available, polychlorinated naphthalenes meet one or more of the criteria set out in section 64 of CEPA 1999. They are persistent and bioaccumulative in accordance with the Persistence and Bioaccumulation Regulations, their presence in the environment results primarily from human activity, and they are not a naturally occurring radionuclides or naturally occurring inorganic substances; therefore, they meet the criteria set out in subsection 77(4) of CEPA 1999. As such, risk management measures are being proposed to achieve the objective of virtually eliminating releases of polychlorinated naphthalenes.

The ecological screening assessment report for chlorinated naphthalenes as well as the proposed risk management approach document are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[27-1-o]

DEPARTMENT OF FINANCE

CANADA—TURKEY TAX CONVENTION ACT, 2010

Coming into force of a tax treaty

Notice is hereby given, pursuant to section 6 of Canada—Turkey Tax Convention Act, 2010 (see footnote a), that the Agreement between Canada and the Republic of Turkey for the avoidance of double taxation and the prevention of fiscal evasion with respect to taxes on income and on capital and its Protocol, which were signed on July 14, 2009, and are set out, respectively, in Schedules 1 and 2 to the Act, entered into force on May 4, 2011.

JAMES M. FLAHERTY
Minister of Finance

[27-1-o]

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Food and Drug Regulations — Amendments

Interim Marketing Authorization

Provision currently exists in the Food and Drug Regulations (the Regulations) for the use of allura red as a colouring agent at a maximum level of use of 300 ppm in fish roe (caviar).

Health Canada has received a submission to permit the use of allura red as a colouring agent in lumpfish caviar at a maximum level of use of 1 300 ppm, if used singly. Evaluation of available data supports the safety and effectiveness of allura red as a colouring agent in the production of this food product.

The use of allura red in lumpfish caviar will benefit consumers by increasing the availability of quality food products and by maintaining colour stability over the course of the shelf life. It will also benefit industry through more efficient and improved manufacturing conditions.

Therefore, it is the intention of Health Canada to recommend that the Regulations be amended to permit the use of allura red as a colouring agent in the production of lumpfish caviar at a maximum level of use of 1 300 ppm, if used singly.

As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization is being issued to permit the immediate use of allura red, as indicated above, while the regulatory process is undertaken to amend the Regulations. The standardized food listed above is exempted from the application of sections 6 and 6.1 of the Food and Drug Act, paragraphs B.01.042(a) and (c), section B.16.007 and paragraph B.21.006(m) of the Regulations.

The proposed regulatory amendments would be enabling measures to allow the sale of additional foods containing allura red as a colouring agent. The amendments are supported by the safety assessment and would have low impact on the economy and on the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.

Interested persons may make representations, with respect to Health Canada’s intention to amend the Regulations, within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the contact person identified below.

Contact

Rick O’Leary, Acting Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 251 Sir Frederick Banting Driveway, Address Locator 2203B, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-6625 (fax), sche-ann@hc-sc.gc.ca (email).

May 13, 2011

PAUL GLOVER
Assistant Deputy Minister
Health Products and Food Branch

[27-1-o]

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

Name and position

Order in Council

Dion, Mario

2011-616

Public Sector Integrity Commissioner on an interim basis

 

Haldane, Scott

2011-626

Minister of Indian Affairs and Northern Development

 

Special adviser

 

and

 

First Nation Elementary and Secondary Education — National Panel

 

Chair

 

McQuaid, The Hon. John A.

2011-622

Government of Prince Edward Island

 

Administrator

 

June 18 to 20, 2011

 

June 23, 2011

DIANE BÉLANGER
Official Documents Registrar

[27-1-o]

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

Footnote a
 S.C. 2010, c. 15, s. 4