Canada Gazette, Part I, Volume 147, Number 2: GOVERNMENT NOTICES

January 12, 2013

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 16998

Significant New Activity Notice

(Section 85 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information in respect of the substance aluminate (AlO21-), magnesium (2:1), Chemical Abstracts Service Registry No. 12068-51-8, under section 83 of the Canadian Environmental Protection Act, 1999;

Whereas the substance is not specified on the Domestic Substances List;

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

Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that Act applies with respect to the substance in accordance with the Annex.

PETER KENT
Minister of the Environment

ANNEX

Information Requirements

(Section 85 of the Canadian Environmental Protection Act, 1999)

  1. In relation to the substance aluminate (AlO21-), magnesium (2:1), a significant new activity is any use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 10 kg in any one calendar year.
  2. The following information must be provided to the Minister at least 90 days before the commencement of each proposed significant new activity:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) if the substance is used in consumer products as defined in section 2 of the Canada Consumer Products Safety Act,
      • (i) the information specified in Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the analytical information to determine the primary and secondary particle size of the substance,
      • (iii) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the substance,
      • (iv) the analytical information to determine the primary and secondary particle size of the test substance as administered in the health and ecological toxicity tests required under subparagraph (i), and
      • (v) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the test substance as administered in the health and ecological toxicity tests required under subparagraph (i);
    • (c) in all other cases, the information specified in Schedule 4 to those Regulations;
    • (d) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
    • (e) if known, the three sites in Canada where the greatest quantity of the substance, in relation to the significant new activity, is anticipated to be used or processed and the estimated quantity by site;
    • (f) the identification of the other government agencies, either outside or within Canada, that the person proposing the significant new activity has notified the use of the substance and, if known, the agency's file number, the outcome of the assessment and, if any, the risk management actions in relation to the substance imposed by those agencies; and
    • (g) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

EXPLANATORY NOTE

(This explanatory note is not part of the Significant New Activity Notice.)

A Significant New Activity Notice is a legal instrument issued by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999. The Significant New Activity Notice sets out the appropriate information that must be provided to the Minister for assessment prior to the commencement of a new activity as described in the Notice.

Substances that are not listed on the Domestic Substances List can be manufactured or imported only by the person who has met the requirements set out in section 81 of the Canadian Environmental Protection Act, 1999. Under section 86 of the Canadian Environmental Protection Act, 1999, in circumstances where a Significant New Activity Notice is issued for a new substance, it is the responsibility of every person who transfers the physical possession or control of the substance to notify all persons to whom the possession or control is transferred of the obligation to comply with the Significant New Activity Notice and of the obligation to notify the Minister of the Environment of any new activity and all other information as described in the Notice. It is the responsibility of the users of the substance to be aware of and comply with the Significant New Activity Notice and to submit a Significant New Activity notification to the Minister prior to the commencement of a significant new activity associated with the substance. However, as mentioned in subsection 81(6) of the Canadian Environmental Protection Act, 1999, a Significant New Activity notification is not required when the proposed new activity is regulated under an act or regulations listed on Schedule 2 to the Canadian Environmental Protection Act, 1999.

A Significant New Activity Notice does not constitute an endorsement from Environment Canada or the Government of Canada of the substance to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 16999

Significant New Activity Notice

(Section 85 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information in respect of the substance vanadate (VO31-), magnesium (2:1), Chemical Abstracts Service Registry No. 13573-13-2, under section 83 of the Canadian Environmental Protection Act, 1999;

Whereas the substance is not specified on the Domestic Substances List;

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

Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that Act applies with respect to the substance in accordance with the Annex.

PETER KENT
Minister of the Environment

ANNEX

Information Requirements

(Section 85 of the Canadian Environmental Protection Act, 1999)

  1. In relation to the substance vanadate (VO31-), magnesium (2:1), a significant new activity is
    • (a) any use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 10 kg in any one calendar year; or
    • (b) in all other cases, its use in a quantity greater than 100 kg in any one calendar year:
      • (i) as a fuel additive; or
      • (ii) as a component of engine emissions control equipment.
  2. The following information must be provided to the Minister at least 90 days before the commencement of each significant new activity:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
    • (c) if known, the three sites in Canada where the greatest quantity of the substance, in relation to the significant new activity, is anticipated to be used or processed and the estimated quantity by site;
    • (d) for a significant new activity described in paragraph 1(a):
      • (i) if the substance is used in consumer products as defined in section 2 of the Canada Consumer Products Safety Act,
        • (A) the information specified in Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers),
        • (B) the analytical information to determine the primary and secondary particle size of the substance,
        • (C) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the substance,
        • (D) the analytical information to determine the primary and secondary particle size of the test substance as administered in the health and ecological toxicity tests required under clause (A),
        • (E) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the test substance as administered in the health and ecological toxicity tests required under clause (A), and
        • (F) the analytical information to characterize the water soluble form of the substance; and
      • (ii) in all other cases, the information specified in Schedule 4 to those Regulations;
    • (e) for a significant new activity described in subparagraph 1(b)(i) or 1(b)(ii), the information specified in Schedule 6 to those Regulations, where the data specified in item 7 of this schedule is from an inhalation toxicity study;
    • (f) for a significant new activity described in subparagraph 1(b)(i):
      • (i) the analytical information identifying and quantifying the evaporative and combustion emissions of the substance and the fuel to which it is added, as well as the information identifying and quantifying the evaporative and combustion emissions of the fuel without the substance,
      • (ii) the analytical information describing the effects of the substance and the fuel to which it is added on the operation of an engine and of engine emissions control equipment, as well as the analytical information describing the effects of the fuel without the substance on the operation of the engine and of the equipment, and
      • (iii) the analytical information describing the effects of the substance on the movement of components of the fuel to which the substance is added, including benzene, toluene, ethylbenzene, and xylenes, in soil and aquifers in the eventuality of a fuel spill or leak, including the size of the resulting plume, and the concentration of the fuel components at different points in that plume, as well as the information describing the movements of components of the fuel without the substance in soils or aquifers in the eventuality of a spill or leak, including the size of the resulting plume and the concentration of the components at different points in that plume;
    • (g) for a new activity described in subparagraph 1(b)(ii), the analytical information identifying and quantifying the emissions and combustion products of the substance produced by the system in which it is used;
    • (h) the identification of the other government agencies, either outside or within Canada, that the person proposing the significant new activity has notified the use of the substance and, if known, the agency's file number, the outcome of the assessment and, if any, the risk management actions in relation to the substance imposed by those agencies; and
    • (i) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

EXPLANATORY NOTE

(This explanatory note is not part of the Significant New Activity Notice.)

A Significant New Activity Notice is a legal instrument issued by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999. The Significant New Activity Notice sets out the appropriate information that must be provided to the Minister for assessment prior to the commencement of a new activity as described in the Notice.

Substances that are not listed on the Domestic Substances List can be manufactured or imported only by the person who has met the requirements set out in section 81 of the Canadian Environmental Protection Act, 1999. Under section 86 of the Canadian Environmental Protection Act, 1999, in circumstances where a Significant New Activity Notice is issued for a new substance, it is the responsibility of every person who transfers the physical possession or control of the substance to notify all persons to whom the possession or control is transferred of the obligation to comply with the Significant New Activity Notice and of the obligation to notify the Minister of the Environment of any new activity and all other information as described in the Notice. It is the responsibility of the users of the substance to be aware of and comply with the Significant New Activity Notice and to submit a Significant New Activity notification to the Minister prior to the commencement of a significant new activity associated with the substance. However, as mentioned in subsection 81(6) of the Canadian Environmental Protection Act, 1999, a Significant New Activity notification is not required when the proposed new activity is regulated under an act or regulations listed on Schedule 2 to the Canadian Environmental Protection Act, 1999.

A Significant New Activity Notice does not constitute an endorsement from Environment Canada or the Government of Canada of the substance to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of living organisms— Nitrobacter winogradskyi ATCC 25391, Nitrobacter species 18132-6, Nitrobacter species 16969-4, Nitrosomonas europaea ATCC 25978, Nitrosomonas species 16968-3, Nitrosomonas species 18133-7, Rhodopseudomonas palustris ATCC 17001, Rhodopseudomonas species 18136-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas Nitrobacter winogradskyi ATCC 25391, Nitrobacter species 18132-6, Nitrobacter species 16969-4, Nitrosomonas europaea ATCC 25978, Nitrosomonas species 16968-3, Nitrosomonas species 18133-7, Rhodopseudomonas palustris ATCC 17001, and Rhodopseudomonas species 18136-1 are living organisms on the Domestic Substances List added under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

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

And whereas it is proposed to conclude that these living organisms do 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 these living 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 Act, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

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

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

ANNEX

Summary of the Draft Screening Assessment Report of Nitrobacter Winogradskyi ATCC 25391, Nitrobacter Species 18132-6, Nitrobacter Species 16969-4, Nitrosomonas Europaea ATCC 25978, Nitrosomonas Species 16968-3, Nitrosomonas Species 18133-7, Rhodopseudomonas Palustris ATCC 17001, and Rhodopseudomonas Species 18136-1
Organism Strain/Accession Number
Nitrobacter winogradskyi ATCC 25391
Nitrobacter species 18132-6
Nitrobacter species 16969-4
Nitrosomonas europaea ATCC 25978
Nitrosomonas species 16968-3
Nitrosomonas species 18133-7
Rhodopseudomonas palustris ATCC 17001
Rhodopseudomonas species 18136-1

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Ministers of the Environment and of Health have conducted a screening assessment of eight lower-hazard (Priority C) micro-organism strains. These strains were nominated and added to the Domestic Substances List (DSL) because they were manufactured in or imported into Canada between January 1, 1984, and December 31, 1986, and they entered or were released into the environment without being subject to CEPA 1999 or any other federal or provincial legislation.

Living organisms on the DSL were prioritized into three groups (Priority A, B, C) based on known hazard characteristics. The 27 micro-organisms in the Priority C (lower-hazard) group are being assessed using an expedited approach in parallel with the more complex assessment of 13 micro-organisms in the Priority A (higher-hazard) group with the objective of assessing the entire number of DSL micro-organisms more efficiently and providing greater certainty to industries that use these micro-organisms. The Priority C group was further subdivided into four “lots” for assessment based on their taxonomic classification (genus or species) and their known and potential uses related to their biological properties, and on whether they remain in commerce in Canada. This Notice pertains to Lot 1 of the Priority C group. For more information, please refer to the document Prioritization of Micro-organisms on the Domestic Substances List available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

Where strain-specific data were not available, surrogate information from literature searches was used. Surrogate organisms are identified in each case to the taxonomic level provided by the source. Information identified up to January 2012 was considered for inclusion in the screening assessment report.

Hazard assessment

The eight micro-organisms in Lot 1 are naturally occurring bacteria. None is recognized as a human pathogen by the Public Health Agency of Canada, and no adverse human health effects have been associated with these strains, their genetic material, secondary metabolites or structural components. Similarly, none of these strains are recognized as animal or plant pathogens by the Canadian Food Inspection Agency or by any member country of the International Plant Protection Convention. Furthermore, an in-depth scientific literature search yielded no reports of the presence of virulence factors or evidence of toxicity or pathogenicity towards humans, plants, vertebrates, or invertebrates.

The hazard potential associated with the micro-organisms in Lot 1 was estimated to be low for both the environment and human health.

Exposure assessment

The eight micro-organism strains in Lot 1 are present in a variety of natural environments, but there is little information or data on the level of exposure from these settings. The purpose of the exposure assessment is to characterize human and environmental exposure to these eight strains from their deliberate use in consumer or industrial products used in Canada.

Current and potential uses of Lot 1 micro-organisms are as ingredients in microbial-based products used for bioremediation, biological waste treatment, and municipal waste water treatment; to clean drains and grease traps in restaurants; and to improve water quality in commercial and hobby fish production facilities, and more. Their mode of action is based on their ability to degrade nitrogenous wastes, grease and oils, and man-made chemicals in industrial effluents (e.g. halogenated and aromatic compounds, and active pharmaceutical ingredients).

Human exposure is expected primarily through direct contact with consumer and commercial products containing these micro-organisms. Human exposure through treated water, wastewater effluent or bioremediation sites is not expected to be significant, but environmental flora and fauna may come into contact with these micro-organisms when they are released from commercial, industrial or manufacturing activities.

Given the range of current potential applications of these micro-organisms, and market trends towards increased use of microbial-based products instead of chemical products in certain sectors, the scale and frequency of use of these strains is expected to increase with consequently higher releases to the environment. Conservative assumptions have therefore been applied to the exposure characterization.

Risk assessment

The eight strains are not recognized to cause disease and the routes of exposure are not expected to lead to adverse environmental or human health effects.

Owing to the lack of documented evidence for adverse effects related to these strains in spite of their ubiquity in nature and taking into account the numerous intended and potential uses, the estimated risk from human and environmental exposure resulting from all their known and potential uses is expected to be low for both the environment and human health.

Proposed conclusion

Based on the available information, the substances listed in this assessment 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, that constitute or may constitute a danger to the environment on which life depends, or that constitute or may constitute a danger in Canada to human life or health. It is therefore proposed to conclude that these substances do not meet the criteria as set out in section 64 of CEPA 1999.

The draft screening assessment report as well as additional information on the assessment approach for lower hazard micro-organisms on the Domestic Substances List is available on the Government of Canada's Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF INDUSTRY

COMPETITION ACT

Revised Competition Act pre-merger notification transaction-size threshold for 2013

Pursuant to subsection 110(8) of the Competition Act, I hereby determine that the amount for the year 2013, for the purposes of any of subsections 110(2) to 110(6) of the Competition Act, is eighty million dollars.

CHRISTIAN PARADIS
Minister of Industry

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DEPARTMENT OF INDUSTRY

INVESTMENT CANADA ACT

Amount for the year 2013

Pursuant to subsection 14.1(2) of the Investment Canada Act, I hereby determine that the amount for the year 2013, equal to or above which an investment is reviewable, is three hundred and forty-four million dollars.

CHRISTIAN PARADIS
Minister of Industry and
Minister Responsible for Investment Canada

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