Canada Gazette, Part I, Volume 149, Number 7: GOVERNMENT NOTICES

February 14 , 2015

DEPARTMENT OF CITIZENSHIP AND IMMIGRATION

IMMIGRATION AND REFUGEE PROTECTION ACT

Notice of ministerial instructions respecting Express Entry

Notice is hereby given that the Ministerial Instructions Respecting the Express Entry System, originally published in the Canada Gazette, Part I, on December 1, 2014, will be updated and published in the Canada Gazette periodically.

For the most up-to-date and complete Ministerial Instructions Respecting the Express Entry System, please refer to the Citizenship and Immigration Canada (CIC) Web site at http://www.cic.gc.ca/english/department/mi/.

Note: The Ministerial Instructions Respecting Invitations to Apply for Permanent Residence under the Express Entry System (authorized under paragraphs 10.3(1)(i) and (j) of the Immigration and Refugee Protection Act) will only be published on the CIC Web site.

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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

Whereas the living organism Pseudomonas fluorescens ATCC 13525 is specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of this living organism under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

And whereas the Ministers suspect that a significant new activity in respect of the living organism may result in this living organism becoming toxic within the meaning of section 64 of the Act;

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 (see footnote c), to indicate that subsection 106(3) of that Act applies to any significant new activities relating to the living organism in accordance with the Annex.

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, Department of the Environment, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca (email).

The screening assessment report for this substance may be obtained from the Government of Canada’s Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/micro/priorita-eng.php.

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
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

ANNEX

1. Part 5 of the Domestic Substances List (see footnote d) is proposed to be amended by deleting the following under the heading “Organisms/Organismes”:

Pseudomonas fluorescens
ATCC 13525

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

Column 1

Living organism

Column 2

Significant New Activity for which the living organism is subject to subsection 106(3) of the Act

Pseudomonas fluorescens ATCC 13525 S′
  1. Any activity involving the living organism Pseudomonas fluorescens ATCC 13525 in a product intended to be used:
    • (a) in health care facilities, including hospitals, doctor’s offices, walk-in clinics, mobile health clinics, long-term care facilities and nursing homes;
    • (b) in blood donor clinics operated by Canadian Blood Services or Héma-Québec, whether in vehicles, public spaces or facilities.
  2. The following information must be provided to the Minister at least 120 days before the commencement of the proposed significant new activity:
    • (a) a description of the significant new activity in relation to the living organism;
    • (b) the information specified in sub-items 1(a) and (g), sections 2 and 3, paragraph 6(e), and section 7 of Schedule 1 to the New Substances Notification Regulations (Organisms);
    • (c) the identification of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided notice in respect of the living organism and the purpose of that notification;
    • (d) the name, civic and postal addresses, telephone number, and, if any, the fax number and email address of the person proposing the significant new activity and, if any, of the person authorized to act on their behalf;
    • (e) the name, civic and postal addresses, telephone number, and, if any, the fax number and email address of the head of the quality assurance unit of every laboratory that developed test data included in the information; and
    • (f) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person authorized to act on their behalf.
  3. 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.

EXPLANATORY NOTE

(This explanatory note is not part of the Notice of Intent.)

Description

The Notice of Intent is an opportunity for the public to comment on the proposed amendment to the Domestic Substances List (DSL) to apply the Significant New Activity (SNAc) provisions to the living organism Pseudomonas fluorescens ATCC 13525, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). (see footnote 1)

Within 60 days of publication of the Notice of Intent, any person may submit comments to the Minister of the Environment, and comments will be taken into consideration during the development of the Order amending the DSL to apply the SNAc provisions to this living organism.

The DSL amendment is not in force until the Order is adopted by the Minister pursuant to subsection 112(3) of CEPA 1999. The Order will be published in the Canada Gazette, Part II.

Applicability of the proposed Order

At this time, it is proposed that the Order amending the DSL require any person engaging in a significant new activity in relation to P. fluorescens ATCC 13525 to submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 120 days prior to the import, manufacture or use of the living organism for the significant new activity.

An example of a potential activity requiring a SNAN with respect to P. fluorescens would include, but would not be limited to, its use in products that are used in health care facilities and in blood donor clinics. This activity is not known to be occurring in Canada.

Activities not subject to the proposed Order

Potential uses of P. fluorescens that would not be of concern include pulp and paper and textile processing; municipal and industrial wastewater treatment; waste degradation, particularly in petroleum refineries; bioremediation and biodegradation; commercial and household drain cleaners and degreasers; enzyme and chemical production; septic tank additives; and general cleaning and odour-control products. These uses would not increase exposure of susceptible individuals to P. fluorescens ATCC 13525, nor would they potentially contaminate medical devices or stored blood products.

The Order amending the DSL proposed in the Notice of Intent above would not apply to uses of the substance that are regulated under any Act of Parliament listed in Schedule 4 of CEPA 1999, including but not limited to the Pest Control Products Act, the Fertilizers Act and the Feeds Act. It would also not apply to impurities and contaminants related to the preparation of a living organism, and in some circumstances to items such as, but not limited to, wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the Order. See subsection 106(6) and section 3 of CEPA 1999, and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms for additional details. (see footnote 2)

Information to be submitted

The Notice of Intent sets out the proposed requirements for information that would need to be provided to the Minister 120 days before the day on which the substance is imported, manufactured or used for a significant new activity. Environment Canada and Health Canada will use the information submitted in the SNAN to conduct human health and environmental assessments within 120 days after the complete information is received.

The information requirements proposed by the Notice of Intent relate to general information in respect of the living organism, details surrounding its use, and exposure information.

Some of the proposed information requirements set out in the Notice of Intent reference the New Substances Notification Regulations (Organisms), (see footnote 3) which describe in more detail the specific information that would be requested. Additional guidance on preparing a SNAN can be found in section 7 of the Guidelines for the Notification and Testing of New Substances: Organisms.

Compliance

When assessing whether or not a particular SNAc applies, (see footnote 4) a person is expected to make use of information in their possession or to which they ought to have access. The phrase “to which they ought to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Material Safety Data Sheet (MSDS).

Although an MSDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the MSDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an MSDS may not list all product ingredients that may be subject to SNAc provisions due to public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that this living organism is toxic or capable of becoming toxic, the person who is in possession or has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of CEPA 1999, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession and control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999, provides more detail on this subject. (see footnote 5)

Any person who transfers the physical possession or control of a substance subject to a SNAc provision should notify all persons to whom the physical possession or control is transferred of the obligation to comply with the SNAc provision, including the obligation to notify the Minister of any significant new activity and to provide all the required information outlined above.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

If a person has questions concerning their obligations to comply with a SNAc provision, believes they may be out of compliance or would like to request a PNC, they are encouraged to contact the Substances Management Information Line (see footnote 6) for help complying with the SNAc provision.

CEPA 1999 is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 7) In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent and history of compliance.

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DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 15024

Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment has previously imposed Significant New Activity Notice No. 15024 pertaining to the substance Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), tris[N-[methyl-3-[[(nonylphenoxy)carbonyl]amino]phenyl]carbamate], Chemical Abstracts Service Registry No. 959468-05-4, on May 10, 2008;

Whereas the Minister of the Environment and the Minister of Health have assessed additional information pertaining to the substance;

And whereas the ministers no longer 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 hereby indicates pursuant to subsection 85(2) that subsection 81(4) of the Canadian Environmental Protection Act, 1999 no longer applies to the substance and rescinds Significant New Activity Notice No. 15024.

LEONA AGLUKKAQ
Minister of the Environment

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a living organism — Pseudomonas fluorescens ATCC (see footnote 8) 13525 (P. fluorescens) — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas P. fluorescens ATCC 13525 is a living organism on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the final Screening Assessment conducted on this living organism pursuant to paragraph 74(b) of the Act is annexed hereby;

Whereas it is concluded that this living organism does not meet any of the criteria set out in section 64 of the Act;

And whereas the Minister of the Environment intends to amend the Domestic Substances List, under subsection 112(3) of the Act, to indicate that subsection 106(3) thereof applies with respect to this living organism,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on this living organism at this time under section 77 of the Act.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Final Screening Assessment of P. fluorescens ATCC 13525

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment on Pseudomonas fluorescens ATCC 13525.

P. fluorescens is considered to be a ubiquitous bacterium and it has the ability to adapt to and thrive in soil and on plants and aqueous surfaces. Multiple potential uses of P. fluorescens in various industrial and commercial sectors exist. These include pulp and paper and textile processing; municipal and industrial wastewater treatment; waste degradation, particularly in petroleum refineries; bioremediation and biodegradation; commercial and household drain cleaners and degreasers; enzyme and chemical production; septic tank additives; and general cleaning and odour-control products. Other uses include pest control, plant growth promotion and use as an anti-frost agent on plants.

There is no evidence from the scientific literature to suggest that P. fluorescens ATCC 13525 is likely to have a significant impact on animal and plant populations in the environment.

There have been no reported infections in humans attributed specifically to the strain P. fluorescens ATCC 13525. Information from the scientific literature indicates that strains of P. fluorescens are unlikely to infect the general Canadian population, but that they can infect humans with compromised immunity, and that human outbreaks, associated with contaminated medical devices and fluids, have been reported. P. fluorescens can also grow at temperatures typical of refrigerated storage, a characteristic which has enabled it to proliferate in stored blood products and cause sepsis in transfused patients.

This assessment considered human and environmental exposure to P. fluorescens ATCC 13525 from its deliberate use in household or commercial products or in industrial processes in Canada. The Government launched a mandatory information-gathering survey (notice) under section 71 of CEPA 1999 as published in the Canada Gazette, Part I, on October 3, 2009. Information submitted in response to the notice indicates that 100 to 1 000 kg of products containing P. fluorescens ATCC 13525 were imported into or manufactured in Canada in 2008.

Based on the information available, it is concluded that P. fluorescens ATCC 13525 does not meet the criteria under paragraph 64(a) or (b) of CEPA 1999 as it 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. It is also concluded that P. fluorescens ATCC 13525 does not meet the criteria under paragraph 64(c) of CEPA 1999 as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that P. fluorescens ATCC 13525 does not meet any of the criteria set out in section 64 of CEPA 1999.

Although current exposures to P. fluorescens ATCC 13525 are not proposed to be harmful to human health, uses that could increase exposure of susceptible individuals to P. fluorescens ATCC 13525 or that could contaminate medical devices or stored blood products are of potential concern. The Public Health Agency of Canada has assigned P. fluorescens to Risk Group 1 (low individual and community risk) and so it is not regulated as a human pathogen. The Government is therefore proposing a measure that will allow it to better define the risk to human health from specified new activities before they begin.

Because P. fluorescens ATCC 13525 is listed on the Domestic Substances List, its import into and manufacture in Canada are not subject to notification under the New Substances Notification Regulations (Organisms). Since there is a potential risk to susceptible humans with compromised immunity, or those exposed through contaminated medical devices or blood products, there is a suspicion that new activities that have not been identified or assessed could lead to P. fluorescens ATCC 13525 meeting the criteria set out in section 64 of CEPA 1999. Therefore, the Government of Canada is considering amending the Domestic Substances List, under subsection 112(3) of the Act, to indicate that the Significant New Activity (SNAc) provisions under subsection 106(3) of the Act apply with respect to the living organism.

A significant new activity can include one that has not been conducted with the living organism in the past or an existing one with a different quantity or in different circumstances that could affect the exposure patterns of the living organism. The SNAc provisions trigger an obligation for a person to notify the Minister of the Environment of any new activity and the Government to assess information about a living organism when a person proposes to use the living organism in a significant new activity. The provisions are used to assess the risks associated with the proposed new activity before the new activity is undertaken. The Minister of the Environment and the Minister of Health assess the information provided by the notifier and other information available to them to determine whether the living organism, if used in the proposed new activity, could pose a risk to the environment or human health and, if so, whether new or additional risk management is required.

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

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of living organisms — Nitrococcus sp. strain 16972-7 (see footnote 9) and Nitrosococcus sp. strain 16971-6 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Nitrococcus sp. strain 16972-7 and Nitrosococcus sp. strain 16971-6 are living organisms on the Domestic Substances List identified under subsection 105(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the final Screening Assessment conducted on these micro-organisms, pursuant to paragraph 74(b) of the Act, is annexed hereby;

Whereas 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 Minister of the Environment and the Minister of Health propose to take no further action on these living organisms at this time under section 77 of the Act.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Final Screening Assessment of Nitrococcus sp. 16972-7 and Nitrosococcus sp. 16971-6
Organism Strain/Accession Number
Nitrococcus sp. 16972-7
Nitrosococcus sp. 16971-6

Pursuant to paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a screening assessment on two lower-hazard micro-organism strains.

The two micro-organisms in Lot 2, Nitrococcus species strain 16972-7 and Nitrosococcus species strain 16971-6, are naturally occurring bacteria that thrive mainly in marine, coastal and brackish waters. Neither is recognized as a human or animal 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, neither of these strains is recognized as a plant pathogen by the Canadian Food Inspection Agency. 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. These observations are supported by the general understanding of the roles played by these micro-organisms in nature, which do not suggest a potential for pathogenic effects, and by genomic sequencing and analysis, which did not identify attributes associated with pathogenicity.

The hazard potential associated with Nitrococcus species strain 16972-7 and Nitrosococcus species strain 16971-6 was estimated to be low for both the environment and human health.

There are no current uses for the two micro-organism strains in Lot 2; however, their ability to degrade nitrogenous compounds makes them of potential use as ingredients in microbial-based products used for the maintenance of aquaria and ornamental ponds, wastewater treatment, and soil biodegradation; in pharmaceuticals or personal care products; and for the production of enzymes.

If potential uses were realized, human exposure would occur primarily through direct contact with consumer, household and commercial products containing these micro-organisms and would be expected to be moderate. Indirect exposure through treated aquarium and pond water, wastewater and industrial effluents, or biodegraded soil is not expected to be significant. If Nitrosococcus sp. 16971-6, specifically, is used in pharmaceuticals or personal care products, direct human exposure could be high, but would depend on the product formulation, frequency of use, and mode of application.

Environmental flora and fauna may come into contact with these micro-organisms when they are released to municipal wastewater and soil, from household, commercial, industrial or manufacturing activities. However, Nitrosococcus sp. and Nitrococcus sp. have growth requirements that are specific to the marine environment, and the Domestic Substances List strains are not expected to persist outside the marine environment.

Given the range of potential applications of these two micro-organism strains, and market trends towards microbial-based products to replace chemical products in certain sectors, the scale and frequency of use of these strains is expected to increase. Conservative assumptions were thus applied to the exposure characterization. Therefore, the exposure associated with Nitrococcus species strain 16972-7 and Nitrosococcus species strain 16971-6 is estimated to be moderate for both the environment and human health.

The two strains in Lot 2 are not known to cause disease, and the routes of exposure are not expected to lead to adverse environmental or human health effects.

Given that these are naturally occurring micro-organisms, given that they play a key role in the ecosystem, and given the lack of documented evidence for adverse effects in the published literature, it is considered that these micro-organisms present a low risk to the environment and human health. Therefore, taking into account the exposures resulting from their numerous potential uses, the estimated risk is expected to be low for both the environment and human health.

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.

Conclusion

It is concluded that Nitrococcus species strain 16972-7 and Nitrosococcus species strain 16971-6 do not meet any of the criteria set out in section 64 of CEPA 1999.

The final Screening Assessment, 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

RADIOCOMMUNICATION ACT

Notice No. SMSE-007-15 — Release of RSS-222, RSS-123, RSS-210 (Amendment 1), DBS-01, CPC-4-1-01, CPC-2-1-11 and CPC-2-1-28

Notice is hereby given that Industry Canada is releasing the following new and revised documents related to the Framework for the Use of Certain Non-broadcasting Applications in the Television Broadcasting Bands Below 698 MHz, announced on October 30, 2012, through Canada Gazette notice SMSE-012-12.

The following new documents are related to television white space devices (WSDs) and white space databases (WSDBs):

The following new and revised documents have been developed and updated to reflect recent equipment certification requirements and licensing authorization changes regarding low-power radio apparatus (LPA), including wireless microphones and wireless cameras in the television bands:

As this document introduces changes to existing processes, CPC-2-1-11 will be provisional for six months, to allow Industry Canada to gather feedback from applicants on any necessary clarifications or improvements to the document.

General information

RSS-222, Issue 1, DBS-01, Issue 1, CPC-4-1-01, Issue 1, RSS-210 (Amendment 1), RSS-123, Issue 3, CPC-2-1-11, Issue 3, and CPC-2-1-28, Issue 1, will come into force immediately.

These documents have been coordinated with industry through the Radio Advisory Board of Canada (RABC).

The Radio Equipment Standards list will be amended accordingly.

Submitting comments

For matters regarding RSS-222, RSS-123 and RSS-210, Amendment 1, please contact the Manager, Radio Equipment Standards (email: res.nmr@ic.gc.ca); for matters regarding CPC-2-1-11 and CPC-2-1-28, please contact the Manager, Operational Policies (email: whitespaceblanc@ic.gc.ca; telephone: 613-608-5178; fax: 613-952-2708); and for matters regarding DBS-01 and CPC-4-1-01, please contact the Manager, Fixed Wireless Planning (email: whitespaceblanc@ic.gc.ca; telephone: 613-302-6849; fax: 613- 952-5108).

Interested parties are requested to provide their comments within 120 days of the date of publication of this notice in electronic format (Microsoft Word or Adobe PDF). Soon after the close of the comment period, all comments received will be posted on Industry Canada’s Spectrum Management and Telecommunications Web site at www.ic.gc.ca/spectrum.

Written submissions should be addressed to the Director General, Engineering, Planning and Standards Branch, 235 Queen Street, Ottawa, Ontario K1A 0H5.

All submissions should cite the Canada Gazette, Part I, the publication date, the title and notice reference number SMSE-007-15.

Obtaining copies

Copies of this notice and of documents referred to herein are available electronically on Industry Canada’s Spectrum Management and Telecommunications Web site at www.ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at www.gazette.gc.ca/rp-pr/p1/index-eng.html.

January 29, 2015

DANIEL DUGUAY
Director General
Engineering, Planning and Standards Branch

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