Vol. 143, No. 2 — January 10, 2009

GOVERNMENT NOTICES

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 15095

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 2,4,7,9-Tetramethyl-4,7-decanediol, Chemical Abstracts Service Registry
No. 17913-76-7;

Whereas the substance is not 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 under the Canadian Environmental Protection Act, 1999,

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

JIM PRENTICE
Minister of the Environment

ANNEX

Information Requirements

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

1. In relation to the substance 2,4,7,9-Tetramethyl-4,7-decanediol, a significant new activity is the use of the substance in Canada, in any quantity, as a component of domestic cleaners or personal care products.

2. A person who proposes a significant new activity set out in this Notice for this substance shall provide to the Minister of the Environment, at least 90 days prior to the commencement of the proposed significant new activity, the following information:

(a) a description of the proposed significant new activity in relation to the substance;

(b) the information specified in Schedule 4 of the New Substances Notification Regulations (Chemicals and Polymers);

(c) the information specified in item 8 of Schedule 5 to those Regulations;

(d) the information specified in item 11 of Schedule 6 to those Regulations; and

(e) the mutagenicity data and a test report obtained from one in vivo mammalian test of the chemical for chromosomal aberrations, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test Guideline No. 475 titled Mammalian Bone Marrow Chromosome Aberration Test, together with data substantiating that the tissue investigated was exposed to the chemical or its metabolites and in conformity with the practices described in the “OECD Principles of Good Laboratory Practice” set out in Annex 2 of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, and that are current at the time the test data are developed.

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

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 of the Canadian Environmental Protection Act, 1999.

A Significant New Activity Notice does not constitute an endorsement from Environment 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. 15330

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 Phosphoric acid, iron(2+) lithium salt (1:1:1);

Whereas the substance is not 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 under the Canadian Environmental Protection Act, 1999,

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

JIM PRENTICE
Minister of the Environment

ANNEX

Information Requirements

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

1. In relation to the substance Phosphoric acid, iron(2+) lithium salt (1:1:1), a significant new activity is any activity involving the use of the substance in quantities greater than 10 kilograms per calendar year, where the substance has a particle size between 1 to 100 nanometres.

2. A person who proposes a significant new activity set out in this Notice for this substance shall provide to the Minister of the Environment, at least 90 days before the day on which the quantity of the substance that has a particle size between 1 to 100 nanometres exceeds 10 kilograms per calendar year, the following information:

(a) a description of the proposed significant new activity in relation to the substance;

(b) measurement of the particle size and particle size distribution of the substance that is involved in the significant new activity;

(c) the requirements specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers) for this substance;

(d) the analytical information to determine the physical dimensions of the test substance for the duration of the health and ecological toxicity tests required pursuant to paragraph 2(c); and

(e) the test data and a test report on the water solubility of this substance that comply with the Organisation for Economic Co-operation and Development series on testing and assessment, Number 29, Guidance Document on Transformation/Dissolution of Metals and Metal Compounds in Aqueous Media.

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

EXPLANATORY NOTE

(This explanatory note is not part of the SignificantNew 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 of the Canadian Environmental Protection Act, 1999.

A Significant New Activity Notice does not constitute an endorsement from Environment 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 HEALTH

FOOD AND DRUGS ACT

Notice of Intent — Food and Drug Regulations — Project No. 1594 — Schedule F

This Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend Part I of Schedule F to the Food and Drug Regulations to revise the listing for Fluconazole to “Fluconazole, except when sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis”.

Fluconazole is currently listed in Part I of Schedule F without any qualifying phrases or exceptions. This means that all strengths of fluconazole currently require a prescription in order to be sold in Canada.

Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.

Description

Fluconazole is a triazole antifungal agent indicated for the treatment of vaginal yeast infections due to Candida. Vaginal candidiasis is a common vaginal yeast infection affecting many women. The proposed non-prescription fluconazole 150 mg would have exactly the same indications for use as the currently available prescription fluconazole 150 mg. Single dose orally administered fluconazole 150 mg has been available in Canada as a prescription drug for treatment of vaginal candidiasis since 1994.

A number of related antifungal products (e.g. clotrimazole, miconazole) that are administered vaginally have been available in Canada without a prescription since 1993. The risk/benefit profile of single dose orally administered fluconazole 150 mg is comparable to that of non-prescription vaginally administered antifungal products. As with the labelling of the non-prescription vaginally administered antifungal products, labelling for the proposed non-prescription fluconazole 150 mg will advise first time sufferers to see their doctor to confirm the diagnosis of a yeast infection. Similarly, the product labelling for the proposed nonprescription fluconazole 150 mg will include a list of symptoms that are not associated with yeast infections; patients will be advised to contact their physician immediately if any of these symptoms are present.

Alternatives

The alternative option would be to leave fluconazole on Schedule F for all dosages and conditions of use. As measured against the factors for listing drugs in Schedule F, it has been determined that maintaining fluconazole in Schedule F for all strengths and conditions of use is not appropriate.

Single dose orally administered fluconazole 150 mg is intended to be used as a stand-alone therapeutic. No adjunctive therapy with scheduled drugs or routine laboratory monitoring are required for the safe use of this drug.

Post-marketing experience has shown that single dose orally administered fluconazole 150 mg is not associated with significant adverse effects. There are no dose-related or age-related adverse effects, no special populations at risk and no clinically significant drug or food interactions. In addition to its large safety margin, side effects associated with the use of single dose orally administered fluconazole 150 mg are minor and transient in nature, with incidence and severity being equivalent to that observed in placebo-treated groups.

Benefits and costs

The proposed amendment would impact on the following sectors:

• Public

The availability of non-prescription single dose orally administered fluconazole 150 mg would provide consumers with another option for the treatment of vaginal candidiasis.

Product labels would be required to include directions for use and applicable cautionary statements. This would help to provide information to the public about the product’s safe and proper use.

The public would be required to pay directly for the product, as products which do not require a prescription are not usually covered by drug insurance plans.

• Health insurance plans

There would be no anticipated cost for privately funded drug benefit plans, since most do not cover the cost of non-prescription drugs.

• Provincial health care services

There would be no anticipated cost to provincial drug benefit plans, since most do not cover the costs of non-prescription drugs.

Compliance and enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations enforced by the Health Products and Food Branch Inspectorate.

Consultation

The process for this consultation with stakeholders is described in the Memorandum of Understanding (MOU) to streamline regulatory amendments to Schedule F, which came into effect on February 22, 2005. The MOU is posted on the Health Canada Web site.

This NOI is being sent by email to stakeholders and is also being posted on the Health Canada Web site and the “Consulting With Canadians” Web site.

Any comments regarding this proposed amendment should be sent within 75 days following the date of publication in the Canada Gazette, Part I. The policy analyst for this project, Karen Ash, may be contacted at the following address: Refer to Project No. 1594, Policy Division, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 0K9, 613-948-4623 (telephone), 613-941-6458 (fax), regaff_access@hc-sc.gc.ca (email).

Final approval

In accordance with the MOU process, it is anticipated that this amendment will proceed directly from this consultation to consideration for final approval by the Governor in Council, approximately six to eight months from the date of publication of this NOI in the Canada Gazette, Part I. If the amendment is approved by the Governor in Council, publication in the Canada Gazette, Part II, would follow. The amendment will come into force on the date of registration.

MEENA BALLANTYNE
Assistant Deputy Minister

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DEPARTMENT OF INDUSTRY

RADIOCOMMUNICATION ACT

Notice No. DGTP-003-08 — Consultation on the possible use of the extended Ku spectrum bands for Direct-to-Home (DTH) satellite broadcasting services

The purpose of this notice is to announce a public consultation on a request to use the extended Ku spectrum bands for Direct-to-Home (DTH) satellite broadcasting services in Canada which, if granted, would require amending the existing policy governing the use of the band.

Discussion

Telesat Canada is authorized to use the extended Ku band on its Anik F1 satellite located at the 107.3°W position and recently received approval to develop the band at the 111.1°W orbital position. As part of its plan, Telesat Canada wants to provide extended Ku capacity for DTH broadcasting.

During a recent satellite licensing initiative, Star Choice, a provider of DTH satellite broadcasting services in Canada, provided support to Telesat in its efforts to secure the award of the extended Ku band at the 111.1°W orbital position. Star Choice indicated that expanding into the adjacent extended Ku bands makes it the most technically compatible with its current system.

A Spectrum Advisory Bulletin (SAB-001-08) has been issued announcing a temporary moratorium on licensing in the bands 10.95-11.2 GHz and 11.45-11.7 GHz while Industry Canada assesses possible policy amendments to the extended Ku band.

Submitting comments

Interested parties should submit their comments no later than March 13, 2009. Soon after the close of the comment period, all comments received and any other relevant information will be posted on Industry Canada’s Spectrum Management and Telecommunications Web site at http://ic.gc.ca/spectrum.

The Department will also provide interested parties with the opportunity to reply to comments from other parties. Reply comments will be accepted until April 17, 2009.

Respondents are requested to provide their comments in electronic format (WordPerfect, Microsoft Word, Adobe PDF or ASCII TXT), along with a note specifying the software, version number and operating system used, to the following email address: wireless@ic.gc.ca.

Written submissions should be addressed to the Director General, Telecommunications Policy Branch, Industry Canada, 300 Slater Street, 16th Floor, Ottawa, Ontario K1A 0C8.

All submissions should cite the Canada Gazette, Part I, the publication date, the title, and the notice reference number (DGTP-003-08).

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 http://ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at http://canadagazette.gc.ca/ partI/index-e.html. Printed copies of the Canada Gazette can be ordered by telephoning the sales counter of Canadian Government Publishing at 613-941-5995 or 1-800-635-7943.

December 22, 2008

LEONARD ST-AUBIN
Director General
Telecommunications Policy Branch

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DEPARTMENT OF INDUSTRY

RADIOCOMMUNICATION ACT

Notice No. DGTP-004-08 — Consultation paper on using a portion of the band 14.5-15.35 GHz for tactical common data link (TCDL) systems

The purpose of this notice is to announce a public consultation on proposed changes to Industry Canada’s 15 GHz spectrum utilization policy in order to accommodate TCDL systems in a portion of the band 14.5-15.35 GHz.

Discussion

The band 14.5-15.35 GHz is allocated to the fixed service on a primary basis and to the mobile service on a secondary basis for the exclusive use of the Government of Canada. The use of the band is currently shared by the fixed service and by the Government of Canada under a coordination agreement for areas near Canadian Forces Bases in Canada.

The Government of Canada has recently identified a need for the exclusive Canada-wide use of the sub-band pair 14.660-14.820 GHz and 15.135-15.295 GHz. This consultation paper provides an opportunity for comments on the future of this band in Canada, including designation, the band plan and associated licensing information.

A spectrum advisory bulletin, SAB-001-08, has been issued announcing a temporary moratorium on licensing in the bands 14.66-14.82 GHz and 15.135-15.295 GHz, while the Department is assessing possible policy amendments to these bands.

Submitting comments

Interested parties should submit their comments no later than March 13, 2009. Soon after the close of the comment period, all comments received and any other relevant information will be posted on Industry Canada’s Spectrum Management and Telecommunications Web site at http://ic.gc.ca/spectrum.

The Department will also provide interested parties with the opportunity to reply to comments from other parties. Reply comments will be accepted until April 17, 2009.

Respondents are requested to provide their comments in electronic format (WordPerfect, Microsoft Word, Adobe PDF or ASCII TXT) to the following email address: wireless@ic.gc.ca, along with a note specifying the software, version number and operating system used.

Written submissions should be addressed to the Director General, Telecommunications Policy Branch, Industry Canada, 300 Slater Street, 16th Floor, Ottawa, Ontario K1A 0C8.

All submissions should cite the Canada Gazette, Part I, publication date, the title, and the notice reference number (DGTP-004-08).

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 http://ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at http://canadagazette.gc.ca/partI/index-e.html. Printed copies of the Canada Gazette can be ordered by telephoning the sales counter of Canadian Government Publishing at 613-941-5995 or 1-800-635-7943.

December 22, 2008

LEONARD ST-AUBIN
Director General
Telecommunications Policy Branch

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DEPARTMENT OF INDUSTRY

RADIOCOMMUNICATION ACT

Notice No. SMBR-002-08 — Amendments to Broadcast Procedures and Rules (BPR) Nos. 1, 2, 3, 4, 7, 8 and 9 to reflect the technical requirements of Electromagnetic Compatibility Advisory Bulletin No. 2 (EMCAB-2) on overload interference from broadcast transmitters and immunity requirements of radio receiving apparatus and radio-sensitive devices, as well as to reflect the requirements of Client Procedures Circular CPC-2-0-03, Issue 4, on radiocommunication and broadcasting antenna systems and to introduce a set of measures to BPR-3 on FM broadcasting to improve the efficiency of the use of the scarce FM spectrum

Notice is hereby given that Industry Canada is publishing revisions to BPR Nos. 1, 2, 3, 4, 7, 8 and 9 to reflect the requirements for applicants of new broadcasting undertakings or modifications thereof on overload interference to radio receiving apparatus, as well as to radio-sensitive devices. The applicants will now need to assume responsibility for resolving overload-type interference to these apparatus and devices where the measured field strength exceeds 125 dBμV/m and 130 dBμV/m respectively, taking into consideration the immunity requirements of such apparatus as reflected in EMCAB-2. Compliance with these technical requirements is on an operational basis.

Notice is also given that Industry Canada is publishing revisions to BPR Nos. 1, 2, 3, 4, 7, 8 and 9 to reflect its requirements on the siting of antenna supporting structures as included in CPC-2-0-03, Issue 4. The BPR revisions associated with this CPC address

• site sharing;
• land-use consultation and public consultation;
• compliance with Health Canada’s Safety Code 6 guideline for the protection of the general public;
• compliance with the requirements of the Canadian Environmental Assessment Act; and
• compliance with Transport Canada/NAV CANADA aeronautical safety requirements.

Notice is finally given that Industry Canada is publishing revisions to BPR No. 3 to improve the use of the scarce FM spectrum ranging from new spurious emission limits, minimum operating parameters, polarization of the emitted signal to the location of the service contour and short spaced allotments and assignments, as previously announced in Canada Gazette Notice No. SMBR-003-08.

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 http://ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at http://canadagazette.gc.ca/ partI/index-e.html. Printed copies of the Canada Gazette can be ordered by telephoning the sales counter of Canadian Government Publishing at 613-941-5995 or 1-800-635-7943.

December 27, 2008

MARC DUPUIS
Director General
Spectrum Engineering Branch

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