GOVERNMENT NOTICES

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice is hereby given that, pursuant to section 127 of the Canadian Environmental Protection Act, 1999, Disposal at Sea Permit No. 4543-2-06593 authorizing the loading for disposal and the disposal of waste or other matter at sea is approved.

 1. Permittee: The City of Saint John, Saint John, New Brunswick.

 2. Waste or other matter to be disposed of: Dredged material.

 2.1. Nature of waste or other matter: Dredged material consisting of gravel, sand, silt and clay.

 3. Duration of permit: Permit is valid from April 1, 2010, to March 31, 2011.

 4. Loading site(s): Saint John Harbour, New Brunswick, from 45°15.72′ N, 66°01.25′ W to 45°15.27′ N, 66°01.73′ W (NAD83).

 5. Disposal site(s): Saint John Harbour, New Brunswick, from 45°15.72′ N, 66°01.25′ W to 45°15.27′ N, 66°01.73′ W (NAD83).

 6. Method of loading: Dredging will be carried out using a barge-mounted mechanical dredge or excavator.

 7. Method of disposal: Disposal will be carried out by sidecasting.

 8. Total quantity to be disposed of: Not to exceed 2 500 m³ place measure.

 8.1. The Permittee shall submit the procedures to measure or estimate quantities of dredged material disposed of at each disposal site to Mr. Adrian MacDonald, identified in paragraph 12.1. The Department of the Environment shall approve the procedures prior to the commencement of the first dredging operation to be conducted under this permit.

 9. Fees: The fee prescribed by the Ocean Dumping Permit Fee Regulations (Site Monitoring) shall be paid by the Permittee in accordance with those Regulations.

10. Inspection:

10.1. By accepting this permit, the Permittee and their contractors accept that they are subject to inspection pursuant to Part 10 of the Canadian Environmental Protection Act, 1999.

10.2. The Permittee shall ensure that records of all loading and disposal activities are kept on site for the duration of the permit and are available for inspection by any enforcement officer or analyst, for two years following the expiry of the permit.

10.3. Ships operating under the authority of this permit shall be marked in accordance with the Collision Regulations of the Canada Shipping Act when located on or in the waterway.

11. Contractors:

11.1. The loading or disposal at sea referred to under this permit shall not be carried out by any person without written authorization from the Permittee.

11.2. The Permittee shall ensure that all contractors involved in the loading or disposal activity for which the permit is issued adhere to the conditions identified in the permit and are aware of possible consequences of any violation of these conditions.

12. Reporting and notification:

12.1. The Permittee shall provide the following information at least 48 hours before loading and disposal activities commence: name or number of ship, platform or structure used to carry out the loading and/or disposal, name of the contractor including corporate and on-site contact information, and expected period of loading and disposal activities. The above-noted information shall be submitted to

(a) Mr. Adrian MacDonald, Environmental Protection Operations Directorate, Environment Canada, Atlantic Region, Queen Square, 16th Floor, 45 Alderney Drive, Dartmouth, Nova Scotia B2Y 2N6, 902-426-8373 (fax), adrian. macdonald@ec.gc.ca (email);

(b) Mr. Mark Dalton, Environmental Enforcement, Environment Canada, Atlantic Region, Queen Square, 16th Floor, 45 Alderney Drive, Dartmouth, Nova Scotia B2Y 2N6, 902-490-0775 (fax), mark.dalton@ec.gc.ca (email);

(c) Ms. Rachel Gautreau, Canadian Wildlife Service, Environment Canada, 17 Waterfowl Lane, Sackville, New Brunswick E4L 1G6, 506-364-5062 (fax), rachel.gautreau@ec.gc.ca (email); and

(d) Mr. Robert MacDougall, Fisheries and Oceans Canada, P.O. Box 1009, St. George, New Brunswick E5C 3S9, 506-755-5061 (fax), macdougallr@mar.dfo-mpo.gc.ca (email).

12.2. The Canadian Coast Guard office (1-800-686-8676) is to be notified in advance of the commencement of work so that appropriate Notices to Shipping/Mariners may be issued.

12.3. The Permittee shall submit a written report to the Minister, as represented by the Regional Director of the Environmental Protection Operations Directorate, Atlantic Region, c/o Mr. Adrian MacDonald, as identified in paragraph 12.1, within 30 days of either the completion of the work or the expiry of the permit, whichever comes first. This report shall contain the following information: a list of all work completed pursuant to the permit, including the location of the loading and disposal site(s) used, the quantity of matter disposed of at the disposal site(s) and the dates on which disposal activities occurred.

12.4. At all times, a copy of this permit and of documents and drawings referenced in this permit shall be available at the loading site and on all powered ships directly engaged in the loading and disposal operations.

I. R. GEOFFREY MERCER
Environmental Protection Operations Directorate
Atlantic Region
On behalf of the Minister of the Environment

[52-1-o]

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice with respect to Batch 12 Challenge substances

Pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999, notice is hereby given that the Minister of the Environment requires, for the purpose of assessing whether the substances listed in Schedule 1 to this notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in Schedule 2 to this notice who possesses or who may reasonably be expected to have access to the information required in Schedule 3 to this notice, to provide that information no later than April 27, 2010, 3 p.m. Eastern Daylight Saving Time.

Responses to this notice shall be submitted to the Minister of the Environment, to the attention of the DSL Surveys Co-ordinator, Chemicals Management Plan, Gatineau, Quebec K1A 0H3. Inquiries concerning the notice may be directed to DSL Surveys Co-ordinator at the above address, 1-800-567-1999 or 819-953-7156 (telephone), 1-800-410-4314 or 819-953-7155 (fax), DSL.SurveyCo@ec.gc.ca (email).

Pursuant to section 313 of the Act, any person who provides information in response to this notice may submit, with the information, a written request that the information or part of it be treated as confidential.

Pursuant to subsection 71(4) of the Act, the Minister of the Environment may, on request in writing from any person to whom this notice applies, extend the time or times within which the person shall comply with this notice. The person seeking such extension shall submit a request in writing to the Minister of the Environment, to the attention of the DSL Surveys Co-ordinator, Chemicals Management Plan, Gatineau, Quebec K1A 0H3.

MARGARET KENNY
Director General
Chemicals Sector Directorate
GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

SCHEDULE 1

Batch 12 Challenge Substances

Part 1 Substances

¹ CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information 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 of Canada 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.

Part 2 Substances

Part 3 Substance

¹ CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information 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 of Canada 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.

Part 4 Substances

¹ CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information 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 of Canada 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.

Part 5 Substance

¹ CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information 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 of Canada 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.

SCHEDULE 2

Persons Required to Provide Information

1. This notice applies to any person who, during the 2006 calendar year,

(a) manufactured or imported a total quantity greater than 100 kg, at any concentration, of a substance listed in Part 1, Part 2 or Part 3 of Schedule 1 to this notice, whether alone or in a mixture, product or manufactured item;

(b) used a total quantity greater than 1 000 kg, at any concentration, of a substance listed in Part 1, Part 2 or Part 3 of Schedule 1 to this notice, whether alone or in a mixture, product or manufactured item;

(c) manufactured or imported a total quantity greater than 100 kg of a substance listed in Part 4 or Part 5 of Schedule 1 to this notice, whether alone or in a mixture, product or manufactured item that is intended for any type of use within a residence; or

(d) used a total quantity greater than 1 000 kg of a substance listed in Part 4 or Part 5 of Schedule 1 to this notice, whether alone or in a mixture, product or manufactured item that is intended for any type of use within a residence.

2. (1) This notice does not apply to

(a) a substance, whether alone or in a mixture, product or manufactured item, in transit through Canada;

(b) a substance listed in Part 4 of Schedule 1 to this notice, if the substance or product, mixture or manufactured item containing the substance is composed of less than 5% respirable crystalline silica; or

(c) the substance listed in Part 5 of Schedule 1 to this notice, if the substance or product, mixture or manufactured item containing the substance is not available for inhalation.

(2) For the purpose of paragraph 2(1)(b), “respirable crystalline silica” means particles of crystalline silica less than or equal to 10 µm in diameter and available for inhalation.

3. Respondents to this notice who

(a) manufactured a substance listed in Part 1 of Schedule 1 to this notice shall complete sections 3, 4(1), 5, 8 and 9 in Schedule 3 to this notice;

(b) manufactured a substance listed in Part 2 of Schedule 1 to this notice shall complete sections 3, 4(1), 4(2), 4(3), 5, 8 and 9 in Schedule 3 to this notice;

(c) manufactured a substance listed in Part 3 of Schedule 1 to this notice shall complete sections 3, 4(1), 4(3), 5, 8 and 9 in Schedule 3 to this notice;

(d) manufactured a substance listed in Part 4 of Schedule 1 to this notice shall complete sections 3, 4(1), 4(4), 5, 8 and 9 in Schedule 3 to this notice;

(e) manufactured the substance listed in Part 5 of Schedule 1 to this notice shall complete sections 3, 4(1), 4(5), 5, 8 and 9 in Schedule 3 to this notice;

(f) imported a substance listed in Part 1 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 6, 8 and 9 in Schedule 3 to this notice;

(g) imported a substance listed in Part 2 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 4(2), 4(3), 6, 8 and 9 in Schedule 3 to this notice;

(h) imported a substance listed in Part 3 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 4(3), 6, 8 and 9 in Schedule 3 to this notice;

(i) imported a substance listed in Part 4 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 4(4), 6, 8 and 9 in Schedule 3 to this notice;

(j) imported the substance listed in Part 5 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 4(5), 6, 8 and 9 in Schedule 3 to this notice;

(k) used a substance listed in Part 1, 2 and 3 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 7, 8, and 9 in Schedule 3 to this notice;

(l) used a substance listed in Part 4 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 4(4), 7, 8, and 9 in Schedule 3 to this notice; or

(m) used the substance listed in Part 5 of Schedule 1 to this notice, whether alone, in a mixture, in a product or in a manufactured item, shall complete sections 3, 4(1), 4(5), 7, 8, and 9 in Schedule 3 to this notice.

SCHEDULE 3

Information Required

1. The definitions in this section apply in this notice.

“calendar year” means a period of 12 consecutive months commencing on January 1.

“manufacture” includes the incidental production of a substance at any level of concentration as a result of the manufacturing, processing or other uses of other substances, mixtures, or products.

“manufactured item” means an item that is formed into a specific physical shape or design during manufacture and has, for its final use, a function or functions dependent in whole or in part on its shape or design, including, without limitation, clothing, empty storage containers, electrical gear and appliances or parts thereof, office and consumer electronics or parts thereof, tiles, electrical wire, foam slabs or shapes and plastic film, pipes, tubes or profiles, plywood, brake linings, fibres, leather, paper, yarns, dyed fabric, matches, flares, photographic films, and batteries.

“mixture” means a combination of substances that does not produce a substance that is different from the substances that were combined, including a prepared formulation, hydrate, and reaction mixture that are characterized in terms of their constituents.

“product” excludes mixture and manufactured item.

“use” excludes sale, distribution, and repackaging.

2. If the person subject to the notice is a company, response to the notice shall be submitted on a company-wide basis. The person shall include information with respect to each facility in their single response on behalf of the entire company.

3. Persons to whom this notice applies shall provide the following information:

² Federal business number is a nine-digit registration number issued by the Canada Revenue Agency (CRA) to Canadian businesses that register for one or more of the following: corporate income tax; importer/exporter account number; payroll (source) deductions (trust accounts); or goods and services tax. This number can be found on all forms issued to a business by the CRA. The first nine digits that appear on these forms is the Federal business number.

4. (1) For each substance listed in Schedule 1, that a person manufactured, imported or used, whether alone, in a mixture, in a product or in a manufactured item, during the 2006 calendar year, the person shall provide the following information:

4. (3) For each substance listed in Part 2 and Part 3 of Schedule 1, that a person manufactured or imported, whether alone, in a mixture, in a product or in a manufactured item, during the 2006 calendar year, the person shall provide the following information:

6. (2) For each substance listed in Schedule 1, that a person imported whether alone, in a mixture, in a product or in a manufactured item, and sold to a person in Canada during the 2006 calendar year, the person shall provide the following information:

9. (2) For the purpose of paragraphs (1)(c) and (d), provide a list describing each study if more than five studies exist.

¹ CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information 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 of Canada 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.

Attach supplementary sheets, if necessary.

10. For the purpose of this Schedule,

(a) except for section 8, where a substance is to be reported in kilograms it shall be rounded to the nearest kilogram if less than 1 000 kg or rounded to the nearest hundred kilograms if greater than 1 000 kg; and

(b) where code U999 is applicable as an industrial function code, a written description must be provided.

11. For the purposes of sections 5, 6, and 7, the following are the industrial function codes and their corresponding descriptions:

Industrial Function Codes and Corresponding Descriptions

EXPLANATORY NOTE

(This note is not part of the notice.)

The Minister of the Environment and the Minister of Health (the Ministers) published on December 9, 2006, in the Canada Gazette, Part I, the Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment. The Ministers will implement a series of measures regarding certain substances to further protect the health of individuals in Canada and the environment from the potential effects of exposure to these substances. These measures apply to the substances identified by categorization of the Domestic Substances List further to section 73 of the Canadian Environmental Protection Act, 1999.

The Ministers will implement a series of measures regarding these substances to further protect the health of individuals in Canada and the environment from the potential effects associated with exposure to these substances. These measures will

• improve, where possible, persistence and/or bioaccumulation information;
• identify industrial best practices in order to set benchmarks for risk management, product stewardship, and virtual elimination; and
• collect environmental release, exposure, substance and/or product use information.

The notice of intent, published on December 9, 2006, covered a list of 193 substances on which information will be required on a quarterly basis within the next three years. This notice, pursuant to paragraph 71(1)(b) of the Act, requires persons identified in Schedule 2 to this notice to provide information for the twelfth batch, consisting of 16 substances. This information will assist the Ministers to complete the assessment as to whether or not the substances meet the criteria set out in section 64 of the Act, to understand the use of the substances, to assess the need for controls and to improve the information available for decision making.

This notice is published in the Canada Gazette, Part I, under paragraph 71(1)(b) of the Act. This notice requires the persons to whom it applies to provide certain information on their activities with respect to the substances listed in Schedule 1 to this notice.

Pursuant to subsection 71(3) of the Act, every person to whom this notice applies is required to comply with this notice within the time specified in the notice. The time specified in this notice ends April 27, 2010, 3 p.m. Eastern Daylight Saving Time.

Persons who do not meet the requirements to respond may submit online, using the Chemicals Management Plan eSubmissions system, a voluntary Declaration of Non-Engagement for the notice. The system is accessible from the Chemical Substances Web site at www.chemicalsubstances.gc.ca.

Persons, including companies, who have a current or future interest in any Challenge substances may identify themselves online as a “stakeholder” for the substance using the Chemicals Management Plan eSubmissions system. Please identify the substances of interest to your company and specify your activity or potential activity with the substance (import, manufacture, use). You will be included in any future mailings regarding section 71 notices applicable for these substances and may be contacted for further information regarding your activity and interest in these substances. The system is accessible from the Chemical Substances Web site at www.chemicalsubstances.gc.ca.

The Ministers are also inviting the submission of additional information that is deemed beneficial by interested stakeholders, relating to the extent and nature of the management or stewardship of substances listed in the Challenge. Organizations that may be interested in submitting additional information in response to this invitation include those that manufacture, import, export or use this substance whether alone, in a mixture, in a product or in a manufactured item.

A questionnaire is available which provides a detailed template as an example for the submission of this information. Guidance on how to respond to the Challenge questionnaire is also available. The questionnaire and associated guidance are available on the Government of Canada Chemical Substances Web site at www.chemicalsubstances.gc.ca.

Compliance with the Act is mandatory. Subsection 272(1) of the Act provides that

272. (1) Every person commits an offence who contravenes

(a) a provision of this Act or the regulations;

(b) an obligation or a prohibition arising from this Act or the regulations;

(c) an order or a direction made under this Act;

[. . .]

Subsection 272(2) of the Act provides that

272. (2) Every person who commits an offence under subsection (1) is liable

(a) on conviction on indictment, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than three years, or to both; and

(b) on summary conviction, to a fine of not more than $300,000 or to imprisonment for a term of not more than six months, or to both.

Furthermore, with respect to providing false or misleading information, subsection 273(1) of the Act provides that

273. (1) Every person commits an offence who, with respect to any matter related to this Act or the regulations,

(a) provides any person with any false or misleading information, results or samples; or

(b) files a document that contains false or misleading information.

Subsection 273(2) of the Act provides that

273. (2) Every person who commits an offence under subsection (1) is liable

(a) on conviction on indictment, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than three years, or to both, if the offence is committed knowingly;

(b) on summary conviction, to a fine of not more than $300,000 or to imprisonment for a term of not more than six months, or to both, if the offence is committed knowingly;

(c) on conviction on indictment, to a fine of not more than $500,000 or to imprisonment for a term of not more than three years, or to both, if the offence is committed negligently; and

(d) on summary conviction, to a fine of not more than $200,000 or to imprisonment for a term of not more than six months, or to both, if the offence is committed negligently.

The above provisions of the Act have been reproduced for convenience of reference only. If there is any variance between the above provisions and the wording of the Act, the official version of the Act prevails. For all purposes of interpreting and applying the law, readers should consult the official versions of Acts of Parliament.

For additional information on the Act and the Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 and on applicable penalties, please contact the Enforcement Branch at enforcement.environmental@ec.gc.ca. A copy of the Policy is available at the following Internet site: www.ec.gc.ca/CEPAregistry/policies.

Provide your information no later than April 27, 2010, 3 p.m. Eastern Daylight Saving Time to the Minister of the Environment, to the attention of the DSL Surveys Co-ordinator, Chemicals Management Plan, Gatineau, Quebec K1A 0H3. An electronic copy of this notice is available at the following Internet addresses: www.ec.gc.ca/CEPAregistry/notices or www.chemicalsubstances.gc.ca.

[52-1-o]

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 15754

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 Alkyl dioic acid, polymer with carbonic dichloride and carbopolycyclic diol, substituted phenyl ester;

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 Alkyl dioic acid, polymer with carbonic dichloride and carbopolycyclic diol, substituted phenyl ester, a significant new activity is

(a) the use of the substance, in any quantity, in baby bottles or food packaging materials intended for infants up to 18 months of age; or

(b) the use of any quantity of the substance where the quantity of unreacted residual Bisphenol A it contains exceeds 100 kilograms per calendar year.

2. A person that 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 9 to the New Substances Notification Regulations (Chemicals and Polymers);

(c) the information specified in item 5 of Schedule 10 to those Regulations;

(d) for a new activity described in paragraph 1(a), in addition to the information prescribed in paragraphs (a) to (c) and (f), the following information must be provided:

(i) the test data and a test report from a study on the migration of the substance out of the product, conducted according to methodology described in the document from the Food and Drug Administration titled Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations that is current at the time the test data are developed, or any other similar study or information that will permit the assessment of the migration of the substance out of the product,

(ii) the hydrolysis rate of the substance as a function of pH and, if known, an identification of the products of the hydrolysis, and

(iii) any other information in the person’s possession or to which they have access, that will permit the assessment of the exposure of the public to residual Bisphenol A and free Bisphenol A derived from the degradation of the substance;

(e) when the substance is manufactured in Canada as per the new activity described in paragraph 1(b), in addition to the information prescribed in paragraphs (a) to (c) and (f), the following information must be provided:

(i) a brief description of the manufacturing process that details precursors of the substance, reaction conditions (e.g. temperature, pressure, catalysts and reaction stoichiometry), and the nature (batch or continuous) and scale of the process,

(ii) a flow diagram of the manufacturing process that includes features such as process tanks, holding tanks and distillation towers, and

(iii) a brief description of the major steps in process operations, the chemical conversions, the points of entry of all feedstock and the points of release of the substance or Bisphenol A and the process to eliminate environmental releases; and

(f) any other information or data in respect of this substance in the person’s possession or to which they have access, that is relevant in order to determine 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 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 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.

[52-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of twelfth release of technical information relevant to substances identified in the Challenge

Whereas the Government of Canada published on Saturday, December 9, 2006, in the Canada Gazette, Part I, Vol. 140, No. 49, the Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment in which it highlights how it intends to address approximately 200 chemical substances identified as high priorities for action;

Notice is hereby given that the Government of Canada is releasing the technical documentation relevant to the 16 substances listed in section 3 of Schedule 1 to this notice. The Government of Canada challenges interested parties to submit the specific information detailed in the technical documentation.

The technical documentation and associated deadlines for submission of information are available via the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances. gc.ca). They may also be obtained by contacting by mail the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3. The Division may also be contacted by fax at 819-953-7155, by email at DSL.SurveyCo@ec.gc.ca, or by telephone at 1-800-567-1999 or 819-953-7156.

A notice concerning a survey for certain substances listed in section 3 of Schedule 1 to this notice is simultaneously published under paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 in this edition of the Canada Gazette, Part I.

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.

GEORGE ENEI
Acting Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
MARGARET KENNY
Director General
Chemicals Sector Directorate
On behalf of the Minister of the Environment
KAREN LLOYD
Director General
Safe Environments Directorate
On behalf of the Minister of Health

SCHEDULE 1

Plan for the assessment and management of certain substances on the Domestic Substances List and list of Batch 12 Challenge substances

1. Background

The Canadian Environmental Protection Act, 1999 (CEPA 1999) required that the Government review some 23 000 Domestic Substances List (DSL) substances to determine whether they have certain characteristics which indicate that the Government should assess the risks that may be associated with their continued use in Canada. The Government completed this exercise — called categorization — in September 2006. Categorization provided a new information baseline on all identified substances, one that will allow the Government of Canada to work with its partners to achieve tangible results that protect Canadians and the environment.

The Ministers of the Environment and of Health (the Ministers) published on December 9, 2006, in the Canada Gazette, Part I, Vol. 140, No. 49, the Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment. The notice indicated that approximately 200 of the 4 300 chemical substances identified through the categorization exercise are high priorities for action under the initiative known as the Challenge because

• The Ministers consider that evidence that a substance is both persistent and bioaccumulative (according to the Persistence and Bioaccumulation Regulations), when combined with evidence of toxicity and release into the environment, can lead to harmful ecological impacts. This indicates that the substance meets the criterion in paragraph 64(a) of CEPA 1999;
• The Ministers consider that where there is evidence that a substance for which the critical health effect is assumed to have no threshold — i.e. a mutagenic carcinogen — it is assumed that there is a probability of harm to human health at any level of exposure, and therefore indicates that the substance meets the criterion in paragraph 64(c) of CEPA 1999;
• The Ministers consider that evidence that a substance exhibits carcinogenicity, mutagenicity, developmental toxicity, or reproductive toxicity, and a high likelihood of exposure to individuals in Canada, indicates that the substance may meet the criterion in paragraph 64(c) of CEPA 1999; and
• These substances are believed to be in commerce or of commercial interest in Canada.

This notice also outlines the measures the Ministers intend to take regarding these substances to further protect the health of Canadians and the environment. These measures will

• improve, where possible, persistence and/or bioaccumulation information;
• identify industrial best practices in order to set benchmarks for risk management, product stewardship, and virtual elimination; and
• collect information on environmental release, exposure, substance and/or product use.

In so doing, the Ministers will make timely risk management interventions that minimize the risk of serious or irreversible harm associated with the above substances.

Pursuant to paragraph 74(a) of the Act, the Ministers are required to conduct a screening assessment of the substances on the DSL that are identified to be substances described in the criteria set forth in subsection 73(1) to determine whether the substances meet one or more of the criteria established in section 64 of the Act.

The Ministers have, for each of the 16 substances in Batch 12 of the Challenge, compiled all information in their possession relevant to categorization and have prepared documentation which (a) summarizes the scientific information and any relevant uncertainties; (b) specifies the information necessary for improved decision making and, where appropriate, requires submission of this data using section 71; and (c) outlines how this information will be used in decisions.

Information considered necessary for improved decision making is being gathered through the means provided under section 71 of CEPA 1999. Additional information regarding the scientific properties of these substances or best management practices associated with the use of these substances, that is considered beneficial by interested stakeholders, will also be collected, as detailed in the technical documentation available via the Government of Canada Chemical Substances Web site (www. chemicalsubstances.gc.ca). The absence of new information will not preclude the Ministers from issuing a decision that safeguards human health and the environment.

2. Timelines

If new information for the 16 substances listed below is not received by June 23, 2010, then, by no later than October 2, 2010, the Ministers will open a 60-day public comment period with respect to all substances assessed under section 74 on (a) the draft screening assessment, and (b) the proposal to pursue one of the measures, as described under subsection 77(2).

If new information is received by June 23, 2010, that information will be considered and, by no later than January 8, 2011, the Ministers will open a 60-day public comment period with respect to all substances assessed under section 74 on (a) the draft screening assessment and (b) their proposal to pursue one of the measures as described under subsection 77(2) and, where applicable, the implementation of virtual elimination under subsection 65(3).

Discussions with stakeholders on the development of the risk management approach, where applicable, will be initiated at the time of the publication of the draft screening assessment. The Ministers will publish their final recommendations under subsection 77(6) by no later than April 9, 2011, where no new information was received during this call for information, and by no later than July 16, 2011, where new information was received during this call for information. A risk management approach, where applicable, will be available at that time, outlining actions which the Government proposes to take to protect Canadians and their environment from risks associated with these substances.

3. Batch 12 Challenge substances

A. Eleven substances identified as persistent, bioaccumulative, and inherently toxic to non-human organisms and believed to be in commercial use in Canada

 * Substances for which no response was received to the notice published in the Canada Gazette, Part I, Vol. 140, No. 9, under section 71 of the Canadian Environmental Protection Act, 1999, on March 4, 2006, but for which stakeholders indicated in their Declaration of Non-Engagement forms an interest in the substances.

** Substance added to the Challenge as a result of information received during public comments on the December 9, 2006, Notice with respect to the draft screening assessment report on 148 Persistent, Bioaccumulative and Inherently Toxic (PBiT) substances published in the Canada Gazette, Part I, along with a notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions under subsection 81(3) of the Canadian Environmental Protection Act, 1999 to these 148 substances.

B. Five substances identified as a high hazard to humans and a high likelihood of exposure to individuals in Canada

¹ Pyridine alkyl derivatives was identified as a potential concern to human health based on its classification by international organizations as a substance which was found to cause cancer when it contains ≥ 0.1% w/w benzene, and based on what was believed to be a high potential for exposure to Canadians.

EXPLANATORY NOTE

The Canadian Environmental Protection Act, 1999 (CEPA 1999) required the Minister of Health and the Minister of the Environment to categorize the approximately 23 000 substances on the Domestic Substances List. Based on the information obtained through the categorization process, a number of substances have been identified by the Ministers as high priorities for action. This includes substances

• that were found to meet all of the ecological categorization criteria, including persistence, bioaccumulation potential and inherent toxicity to aquatic organisms, and that are known to be in commerce, or of commercial interest, in Canada; and/or
• that were found either to meet the categorization criteria for greatest potential for exposure or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity.

The Challenge initiative is meant to engage stakeholders to provide new information that could improve decision-making with respect to 200 substances identified as high priorities for action.

In the absence of additional relevant information as a result of this Challenge, the Ministers are predisposed to conclude, through a screening assessment, that a substance satisfies the definition of toxic under section 64 of CEPA 1999 in that it “may 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 may constitute a danger in Canada to human life or health.” As such, the Ministers may then recommend to the Governor in Council that this substance be added to the List of Toxic Substances in Schedule 1 of CEPA 1999, with the intent of initiating the development of risk management measures taking into account socio-economic considerations. The measures will be subject to review in light of new scientific information, including monitoring and ongoing assessment activities.

The 200 Challenge substances are in commerce or believed to be in commerce in Canada. Should no information be forthcoming through this Challenge to confirm that a substance is in commerce in Canada, the Ministers may conclude, through a screening assessment or investigation, that the substance is not currently in commerce in Canada and that, as such, it may not satisfy the criteria under section 64 of CEPA 1999. However, given the hazardous properties of these substances, there is concern that new activities for the substances that 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. It will be recommended that such substances be 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 that ecological and human health risk assessments are conducted as specified in section 83 of the Act prior to the substances being introduced into Canada.

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of Intent — Food and Drug Regulations — Project No. 1577 — Schedule F

The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listings in Parts I and II of Schedule F to the Food and Drug Regulations by removing the listings for four medicinal ingredients, thus allowing them to have non-prescription status.

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.

Since the coming into force of the Natural Health Products Regulations in 2004, all naturally sourced substances meeting the definition of a natural health product are governed by these Regulations. However, products containing substances listed in Schedule F to the Food and Drug Regulations are explicitly excluded from the Natural Health Products Regulations.

Health Canada has undertaken a review of the naturally sourced medicinal ingredients listed in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee (“the Committee”) has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these medicinal ingredients could be regulated (in whole or in part) as non-prescription natural health products under the Natural Health Products Regulations. The Committee recommends prescription status or exemption from prescription status for medicinal ingredients on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients. Four of these eleven medicinal ingredients are presented in this project.

Health Canada is proposing that the following four medicinal ingredients be removed from Schedule F to the Food and Drug Regulations as none of the factors for listing in Schedule F were found to apply. This would mean that products containing these medicinal ingredients would not require a prescription to be sold in Canada and that manufacturers could apply for market authorization for these medicinal ingredients as natural health products pursuant to the Natural Health Product Regulations.

Description of the medicinal ingredients:

Apiol, oil of — Apiol oil is found in the essential oils of parsley seed, dill seed, and, to a lesser extent, in fennel seed, sassafras root bark and other plant species. Apiol oil is currently regulated as a prescription drug although there are presently no known marketed prescription products that contain apiol oil. A review of the available scientific literature indicates that there is a wide margin of safety between the therapeutic and toxic doses of apiol oil. It has toxic effects in humans exposed to doses of approximately 1 g/day; however, the common presence of apiol oil in foods indicates a lack of toxicity at doses likely to be found in herbal medicines. No health hazards or side effects are known in conjunction with appropriate therapeutic dosages of parsley seed, whose medicinal properties are largely attributed to the apiol volatile oil content, and there are no reports of serious health risks associated with normal dietary ingestion or recommended medicinal use of parsley seed.

Centella asiatica extract and active principles thereof — Centella asiatica extract is derived from a small plant commonly known as gotukola. Centella asiatica extract is a concentrated preparation. An active principle is the part of the drug upon which the therapeutic action of the drug depends. Centella asiatica extract and active principles thereof have prescription status in Canada although there are presently no known marketed prescription products that contain Centella asiatica extract and active principles thereof. Centella asiatica crude herb does not have prescription status and is regulated as a natural health product. It is also available as a vegetable in South Asian markets. A review of the available scientific literature indicates that there is a wide margin of safety between the therapeutic and toxic doses of Centella asiatica extract. Centella asiatica extract and active principles thereof pose a low risk of undesirable or severe side effects. There is a very low percentage of adverse reactions compared to its length and frequency of use both in food and medicine.

Deanol and its salts and derivatives — Deanol, also known as dimethylaminoethanol or DMAE, is a naturally sourced chemical found in salmon roe, shellfish and fish oils. Deanol and its salts and derivatives have prescription status in Canada although there are presently no known marketed prescription products containing deanol. Deanol is a precursor to choline, a chemical in the body used to make acetylcholine, a chemical that is found in the brain and other areas of the body. A review of the available scientific literature indicates that deanol does not have a narrow margin of safety between the therapeutic and toxic doses.

Theobromine and its salts — Theobromine is a naturally occurring chemical substance that is found in cocoa and chocolate and is also prepared synthetically for commercial purposes. Theobromine and its salts have prescription status in Canada although there are presently no known marketed prescription products that contain theobromine. Theobromine affects humans similarly to caffeine, but to a lesser degree. Toxicity from the use of theobromine is very rare and is only seen at very high doses in humans; therefore, it does not possess a high level of risk relative to expected benefits. As well, theobromine has no known severe side effects at normal therapeutic dosage levels. Due to theobromine’s low potency as a drug and the availability of more effective treatments, it is rarely used therapeutically anymore.

Alternatives

The alternative option would be to leave these four medicinal ingredients in Schedule F. As measured against the factors for listing drugs in Schedule F, it has been determined that maintaining the current listings in Schedule F for these four medicinal ingredients is not appropriate.

As well, any alternatives to the degree of regulatory control recommended in this amendment would need to be established through additional scientific information and clinical experience.

Benefits and costs

• Public

The public may benefit by potentially having access to licensed natural health products that would otherwise have required a prescription because they contain trace amounts of Schedule F medicinal ingredients. Any potential safety concerns for products containing these non-prescription medicinal ingredients would be addressed during the premarket review process under the Natural Health Products Regulations, a review which determines whether the product meets the safety, efficacy, and quality requirements of the Regulations and which provides for risks to be mitigated through recommended conditions of use and risk information including cautions, warnings, contraindications or known adverse reactions associated with its use, as appropriate.

• Manufacturers

Manufacturers may benefit by being provided an opportunity to apply for product licences for natural health products containing these ingredients.

There would be no immediate impact on manufacturers as there are currently no known prescription products containing these medicinal ingredients on the market in Canada.

• Health insurance plans

There would be no change in costs to drug benefit plans as there are no known prescription drugs containing these medicinal ingredients on the market in Canada. Should natural health products containing these medicinal ingredients proposed for removal from Schedule F receive market authorization from Health Canada, there would be no anticipated additional costs to privately funded drug benefit plans since most do not cover the cost of natural health products.

• Provincial health care services

There would be no change in costs to drug benefit plans as there are no known prescription drugs containing these medicinal ingredients on the market in Canada. Should natural health products containing these medicinal ingredients proposed for removal from Schedule F receive market authorization from Health Canada, there would be no anticipated additional costs to provincial drug benefit plans since most do not cover the cost of natural health products.

Compliance and enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products 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, Carrie Harrison-Viau, may be contacted at the following address: Refer to Project No. 1577, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Health Canada, 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-affreg@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 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 would come into force on the date of registration.

MEENA BALLANTYNE
Assistant Deputy Minister

[52-1-o]

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of Intent — Food and Drug Regulations — Project No. 1651 — Schedule F

The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listings in Part I of Schedule F to the Food and Drug Regulations for four medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages while providing exemptions that would allow non-prescription status.

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.

Since the coming into force of the Natural Health Products Regulations in 2004, all naturally sourced substances meeting the definition of a natural health product are governed by these Regulations. However, products containing substances listed in Schedule F to the Food and Drug Regulations are explicitly excluded from the Natural Health Products Regulations.

Health Canada has undertaken a review of the naturally sourced medicinal ingredients listed in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee (“the Committee”) has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these medicinal ingredients could be regulated (in whole or in part) as non-prescription natural health products under the Natural Health Products Regulations. The Committee recommends prescription status or exemption from prescription status for medicinal ingredients on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients. Four of these eleven medicinal ingredients are presented in this project.

This proposed amendment would allow manufacturers to apply for market authorization for products containing the proposed exempted strengths, uses, routes of administration or dosages of the following four medicinal ingredients as natural health products pursuant to the Natural Health Products Regulations.

Description of the medicinal ingredients:

Dopamine and its salts — The current listing for dopamine and its salts would be revised to retain prescription status for injectable (parenteral) forms of dopamine and its salts. All other dosage forms and routes of administration at any strength and for any use would be exempt from prescription status.

Dopamine is inactive in the body when administered orally. Therefore, there are no oral drug products containing dopamine on the market in Canada. Revising the prescription status of dopamine would mitigate issues with the licensing of orally administered natural health products with ingredients that might naturally contain trace amounts of dopamine.

Dopamine is administered by intravenous injection to treat kidney failure, septic shock and acute heart failure resulting from a heart attack. It works by increasing blood pressure, heart rate and force of heart contraction, and by causing constriction of blood vessels. Administration of dopamine by injection requires direct supervision by a practitioner and can cause serious adverse effects in the therapeutic dosage range. Retaining prescription status for injectable forms of dopamine and its salts is therefore recommended.

Gold and its salts — The current listing for gold and its salts would be revised to retain prescription status for injectable (parenteral) forms of gold and its salts and derivatives. The revised listing would be worded so that it would not change the status of auranofin, an orally administered gold derivative that is listed separately in Schedule F. Gold and its salts and derivatives in any other dosage form or route of administration at any strength and for any use would be exempt from prescription status.

Gold is naturally occurring in trace amounts in nature, so it is appropriate to add qualifiers to the listing on Schedule F to avoid unintentionally subjecting products containing trace amounts of gold to prescription requirements where it is not necessary.

As prescription drugs, gold compounds are administered parenterally (by injection) to treat rheumatoid arthritis in patients for whom other treatments have been unsuccessful. Gold compounds administered by the parenteral route can have undesirable side effects at normal therapeutic dosage levels and require direct practitioner supervision and routine laboratory monitoring.

Lovastatin — The current listing for lovastatin would be revised to retain prescription status for all strengths and dosage forms except when lovastatin is sold in oral dosage form that provides less than 1.0 mg per dosage unit or per daily dose. Oral dosage forms containing less than 1.0 mg of lovastatin would be exempt from prescription status.

The proposed exemption for less than 1.0 mg is only 10% of the lowest therapeutic dose of 10 mg of lovastatin. This would allow red yeast rice products containing only trace amounts of lovastatin to be marketed as natural health products in Canada. Red yeast rice is derived from yeast grown on rice and is used as food in some Asian countries. It contains several substances, including lovastatin, known to reduce cholesterol.

As a prescription drug, lovastatin is available in Canada and is used to treat high cholesterol and is usually given in an initial dose of 10 to 20 mg daily, increased, if necessary, over a period of time to 80 mg daily to achieve target cholesterol levels.

Uracil and its salts — The current listing for uracil and its salts would be revised to retain prescription status for uracil and its salts when sold for the treatment of cancer. Uracil and its salts for other uses at any strength, dosage form or route of administration would be exempt from prescription status. Uracil is found in all living organisms so its listing in Schedule F without qualifiers is inappropriate.

Uracil has been used as a prescription drug in conjunction with other anti-cancer drugs to enhance antitumour activity and to reduce adverse effects. However, this therapeutic use is not currently in practice in Canada. If uracil were used in the treatment of cancer it would require the supervision of a practitioner and laboratory monitoring.

Alternatives

The alternative option would be to leave these four medicinal ingredients in Schedule F for all strengths, dosages, dosage forms and conditions of use. As measured against the factors for listing drugs in Schedule F, it has been determined that maintaining the current listings in Schedule F for these four medicinal ingredients is not appropriate.

As well, any alternatives to the degree of regulatory control recommended in this amendment would need to be established through additional scientific information and clinical experience.

Benefits and costs

• Public

The public may benefit by potentially having access to licensed natural health products that would otherwise have required a prescription because they contain trace amounts of Schedule F medicinal ingredients. Potential safety concerns for products containing these non-prescription medicinal ingredients would be considered during the premarket review process under the Natural Health Products Regulations, a review which determines whether the product meets the safety, efficacy, and quality requirements of the Regulations and which provides for risks to be mitigated through recommended conditions of use and risk information including cautions, warnings, contraindications or known adverse reactions associated with its use, as appropriate.

• Manufacturers

Manufacturers may benefit by being provided an opportunity to apply for product licences for natural health products containing the proposed exempted strengths, uses, routes of administration or dosages of these medicinal ingredients.

There would be no immediate impact on manufacturers as there are currently no known products on the market in Canada for the strengths, uses, routes of administration or dosages proposed for exemption from Schedule F. The status of currently marketed prescription drugs containing these ingredients would not change.

• Health insurance plans

There would be no change in costs to drug benefit plans for prescription drugs containing these medicinal ingredients as their status would not change. Should natural health products containing the proposed exempted strengths, uses, routes of administration or dosages of these medicinal ingredients receive market authorization from Health Canada, there would be no anticipated additional costs to privately funded drug benefit plans since most do not cover the cost of natural health products.

• Provincial health care services

There would be no change in costs to drug benefit plans for prescription drugs containing these medicinal ingredients as their status would not change. Should natural health products containing the proposed exempted strengths, uses, routes of administration or dosages of these medicinal ingredients receive market authorization from Health Canada, there would be no anticipated additional costs to provincial drug benefit plans since most do not cover the cost of natural health products.

Compliance and enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products 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. 1651, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Health Canada, 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-affreg@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 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 would come into force on the date of registration.

MEENA BALLANTYNE
Assistant Deputy Minister

[52-1-o]

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of Intent — Food and Drug Regulations — Project No. 1656 — Schedule F

The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listings in Part I of Schedule F to the Food and Drug Regulations for three medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages, while providing exemptions that would allow non-prescription status.

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.

Since the coming into force of the Natural Health Products Regulations in 2004, all naturally sourced substances meeting the definition of a natural health product are governed by these Regulations. However, products containing substances listed in Schedule F to the Food and Drug Regulations are explicitly excluded from the Natural Health Products Regulations.

Health Canada has undertaken a review of the naturally sourced medicinal ingredients listed in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee (“the Committee”) has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these medicinal ingredients could be regulated (in whole or in part) as non-prescription natural health products under the Natural Health Products Regulations. The Committee recommends prescription status or exemption from non-prescription status for medicinal ingredients on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients. Three of these eleven medicinal ingredients are presented in this project.

This proposed amendment would allow manufacturers to apply for market authorization for products containing the proposed exempted strengths, uses, routes of administration or dosages of the following three medicinal ingredients as natural health products pursuant to the Natural Health Products Regulations.

Description of the medicinal ingredients:

Dimethyl sulfoxide — The current listing for dimethyl sulfoxide (also referred to as DMSO) would be revised to retain prescription status for human use when dimethyl sulfoxide is sold for the treatment of interstitial cystitis or scleroderma and for all veterinary uses. All other human uses for dimethyl sulfoxide at any strength and in any dosage form would be exempt from prescription status. Dimethyl sulfoxide is found in many natural sources such as broad beans, alfalfa and garlic.

Drugs containing dimethyl sulfoxide for human use are available in Canada with a prescription for treatment of interstitial cystitis (a urinary bladder condition) and scleroderma (abnormal growth of connective tissue that supports the skin). Several products are currently available as prescription drugs for veterinary use to treat conditions such as ear inflammation in dogs. These products would retain prescription status.

Levocarnitine — The current listing for levocarnitine (also called L-carnitine) would be revised to retain prescription status for levocarnitine and its salts and derivatives when sold for the treatment of primary or secondary levocarnitine deficiencies. Levocarnitine and its salts and derivatives for any other uses at any strength, dosage form or route of administration would be exempt from prescription status. Levocarnitine occurs naturally in animal products and in small amounts in most plants.

Overall, levocarnitine functions in the body mainly in optimal fat utilization for energy production. Absorption of levocarnitine is high from dietary sources but if dietary intake is low then the body can maintain a balanced level by synthesizing or reducing elimination of levocarnitine. In most people, sufficient quantities of levocarnitine are obtained from the diet or synthesized in order to meet human requirements.

Primary levocarnitine deficiency is a genetically inherited condition related to the processing of levocarnitine in the body and can lead to muscle weakness and death from heart failure. Secondary levocarnitine deficiency syndromes are numerous, and include genetic defects of metabolism. Treatment of these conditions with levocarnitine requires the supervision of a practitioner and routine laboratory monitoring.

L-Tryptophan — The current listing for l-tryptophan when sold as a single ingredient would be revised to provide prescription status for l-tryptophan

— when sold for human use in oral dosage form as a single ingredient or in combination with other ingredients at a concentration of more than 220 mg l-tryptophan per dosage unit or per daily dose; and

— when sold for human use or veterinary use as a single ingredient for any route of administration other than oral use.

L-tryptophan is one of the essential amino acids that cannot be synthesized in the human body and must be provided in the diet. L-tryptophan acts in the body in the formation of the vitamin niacin and the neurotransmitter serotonin.

L-tryptophan is available in Canada as a prescription drug for use in combination with antidepressant drugs to enhance the activity of the antidepressant. L-tryptophan is also sold in combination with other amino acids in kidney dialysis and intravenous nutrition solutions without a prescription. The proposed amendment would not change the status of these products.

Alternatives

The alternative option would be to leave these three medicinal ingredients in Schedule F for all strengths, dosages, dosage forms and conditions of use. As measured against the factors for listing drugs in Schedule F, it has been determined that maintaining the current listings in Schedule F for these three medicinal ingredients is not appropriate.

As well, any alternatives to the degree of regulatory control recommended in this amendment would need to be established through additional scientific information and clinical experience.

Benefits and costs

• Public

The public may benefit by potentially having access to licensed natural health products that would otherwise have required a prescription because they contain trace amounts of Schedule F ingredients. Potential safety concerns for products containing these non-prescription medicinal ingredients would be considered during the premarket review process under the Natural Health Products Regulations, a review which determines whether the product meets the safety, efficacy, and quality requirements of the Regulations and which provides for risks to be mitigated through recommended conditions of use and risk information including cautions, warnings, contraindications or known adverse reactions associated with its use, as appropriate.

• Manufacturers

Manufacturers may benefit by being provided an opportunity to apply for product licences for natural health products containing the exempted strengths, uses, routes of administration or dosages of these medicinal ingredients.

There would be no immediate impact on manufacturers as there are currently no known products on the market in Canada for the strengths, uses, routes of administration or dosages proposed for exemption from Schedule F. The status of currently marketed prescription drugs containing these ingredients would not change.

• Health insurance plans

There would be no change in costs to drug benefit plans for prescription drugs containing these medicinal ingredients as their status would not change. Should natural health products containing the proposed exempted strengths, uses, routes of administration or dosages of these medicinal ingredients receive market authorization from Health Canada, there would be no anticipated additional costs to privately funded drug benefit plans since most do not cover the cost of natural health products.

• Provincial health care services

There would be no change in costs to drug benefit plans for prescription drugs containing these medicinal ingredients as their status would not change. Should natural health products containing the proposed exempted strengths, uses, routes of administration or dosages of these medicinal ingredients receive market authorization from Health Canada, there would be no anticipated additional costs to provincial drug benefit plans since most do not cover the cost of natural health products.

Compliance and enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products 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. 1656, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Health Canada, 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-affreg@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 would come into force on the date of registration.

MEENA BALLANTYNE
Assistant Deputy Minister

[52-1-o]

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

December 17, 2009

DIANE BÉLANGER
Manager

[52-1-o]

DEPARTMENT OF INDUSTRY

CANADA CORPORATIONS ACT

Application for surrender of charter

Notice is hereby given that, pursuant to the provisions of subsection 32(2) of the Canada Corporations Act, an application for surrender of charter was received from

December 17, 2009

AÏSSA AOMARI
Director
Incorporation and Information
Products and Services Directorate
For the Minister of Industry

[52-1-o]

DEPARTMENT OF INDUSTRY

CANADA CORPORATIONS ACT

Letters patent

Notice is hereby given that, pursuant to the provisions of the Canada Corporations Act, letters patent have been issued to

December 17, 2009

AÏSSA AOMARI
Director
Incorporation and Information
Products and Services Directorate
For the Minister of Industry

[52-1-o]

DEPARTMENT OF INDUSTRY

CANADA CORPORATIONS ACT

THE NOURISH AND DEVELOPMENT FOUNDATION — Correction of name

Notice is hereby given that letters patent dated July 8, 2009, were issued under Part II of the Canada Corporations Act to THE NOURISH AND DEVELOPMENT FOUNDATION, corporate No. 452610-4.

As a result of a clerical error, the letters patent were issued containing an error in respect of the corporations’s name. In order to avoid undue hardship to the corporation, the Minister has now corrected the name of the corporation to THE NOURISH AND DEVELOP FOUNDATION.

November 24, 2009

AÏSSA AOMARI
Director
Incorporation and Information
Products and Services Directorate
For the Minister of Industry

[52-1-o]

DEPARTMENT OF INDUSTRY

CANADA CORPORATIONS ACT

Sing*A*Rama Advertising Fund, Inc. — Correction of name

Notice is hereby given that letters patent dated November 30, 2006, were issued under Part II of the Canada Corporations Act to Sing*A*Rama Advertising Fund, Inc., corporate No. 439823-8.

As a result of a clerical error, the letters patent were issued containing an error in respect of the name of the corporation. In order to avoid undue hardship to the corporation, the Minister has now corrected the name of the corporation to Sign*A*Rama Advertising Fund, Inc.

November 25, 2009

AÏSSA AOMARI
Director
Incorporation and Information
Products and Services Directorate
For the Minister of Industry

[52-1-o]

DEPARTMENT OF INDUSTRY

CANADA CORPORATIONS ACT

Supplementary letters patent

Notice is hereby given that, pursuant to the provisions of the Canada Corporations Act, supplementary letters patent have been issued to

December 17, 2009

AÏSSA AOMARI
Director
Incorporation and Information
Products and Services Directorate
For the Minister of Industry

[52-1-o]

DEPARTMENT OF INDUSTRY

CANADA CORPORATIONS ACT

Supplementary letters patent — Name change

Notice is hereby given that, pursuant to the provisions of the Canada Corporations Act, supplementary letters patent have been issued to

December 17, 2009

AÏSSA AOMARI
Director
Incorporation and Information
Products and Services Directorate
For the Minister of Industry

[52-1-o]

NOTICE OF VACANCY

OFFICE OF THE COMMISSIONER OF REVIEW TRIBUNALS

CANADA PENSION PLAN / OLD AGE SECURITY: REVIEW TRIBUNALS

Commissioner (full-time position)

Salary range: $163,000–$191,800

Location: Ottawa, Ontario

In 1991, Parliament created the Canada Pension Plan Review Tribunals with the passage of Bill C-116. In 1995, Bill C-54 gave Review Tribunals additional jurisdiction to hear appeals under the Old Age Security Act. The Review Tribunals were created as a body independent from government that would make determinations regarding eligibility for persons claiming benefits under the Acts mentioned above.

When a person claiming entitlement to a benefit is not satisfied with the decision made by Human Resources and Social Development Canada, that person may appeal to a Review Tribunal under section 82 of the Canada Pension Plan or section 28 of the Old Age Security Act.

A Review Tribunal is an independent body of three persons selected by the Commissioner of Review Tribunals from a Panel of up to 400 individuals appointed by the Governor in Council. The Review Tribunal conducts a hearing and makes a decision regarding eligibility for benefits in individual cases.

The Office of the Commissioner is an independent, quasi-judicial body which has the responsibility of ensuring that hearings are carried out by Review Tribunal Panel Members in communities across the country. The Office of the Commissioner also has responsibility for providing legal advice, technical support, training and other assistance to Panel Members and for ensuring that all parties to an appeal are provided with the proper documentation, notices, and other material that might be necessary to ensure a fair and impartial hearing.

The Commissioner is responsible for the planning, organization and management of the Review Tribunal appeal process to ensure that the process is efficient and fair, and that Panel Members and staff are equipped to carry out their responsibilities.

The successful candidate will have a degree from a recognized university in a relevant field of study or an acceptable combination of equivalent education, training and job-related experience. The preferred candidate will possess executive-level management experience in a private or public sector organization, including managing financial and human resources in addition to demonstrated decision-making experience with respect to sensitive and complex issues. Experience in the interpretation and application of legislation, government policies and directives in a quasi-judicial environment as well as experience in the operation and conduct of a quasi-judicial tribunal, an agency or equivalent would be considered assets.

The suitable candidate will possess knowledge of the legislated mandate and operations of the Office of the Commissioner of Review Tribunals as well as knowledge of the Canada Pension Plan and the Old Age Security Act, the Review Tribunals Rules of Procedure and other related legislation. Familiarity with the appeals process and the operations of an administrative tribunal, including the rules that govern its operations, would be an asset.

The preferred candidate will have the ability to provide intellectual and strategic leadership and to define the objectives and strategies of the organization. The ideal candidate will possess sound management skills in order to motivate members and staff and to ensure the Review Tribunals adhere to the highest standards of accountability and transparency as well as the ability to manage and assess appeals and ensure the efficient assignment of case loads. The ability to develop effective relationships with the Minister and departmental officials while maintaining the degree of independence required of a quasi-judicial tribunal in addition to possessing superior communication skills (written and oral) with the ability to act as a spokesperson when dealing with stakeholders, media, public institutions, governments, the public and other organizations are also required.

The suitable candidate must be an individual of sound judgment and integrity and will adhere to high ethical standards. He/she will demonstrate impartiality, fairness, tact and discretion and will have superior interpersonal skills.

Proficiency in both official languages would be preferred.

The successful candidate must be willing to relocate to the National Capital Region or to a location within reasonable commuting distance as well as be willing to travel for extended periods of time to attend hearings and various other conferences and meetings in all parts of Canada.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The preferred candidate must comply with the Ethical Guidelines for Public Office Holders and the Guidelines for the Political Activities of Public Office Holders. The guidelines are available on the Governor in Council Appointments Web site, under “Reference Materials,” at www.appointments-nominations.gc.ca.

The selected candidate will be subject to the Conflict of Interest Act. Public office holders appointed on a full-time basis must submit to the Office of the Conflict of Interest and Ethics Commissioner, within 60 days of appointment, a Confidential Report in which they disclose all of their assets, liabilities and outside activities. For more information please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca.

This notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, intended to be the sole means of recruitment.

Further details about the organization and its activities can be found on its Web site at www.ocrt-bctr.gc.ca.

Interested candidates should forward their curriculum vitae by January 15, 2010, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@bnet.pco-bcp.gc.ca.

Bilingual notices of vacancies will be produced in an alternative format (audio cassette, diskette, braille, large print, etc.) upon request. For further information, please contact Canadian Government Publishing, Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5, 613-941-5995 or 1-800-635-7943.

[52-1-o]

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person of the Royal Canadian Mounted Police as a fingerprint examiner:

Bobby Steven Zwarich

Ottawa, December 3, 2009

RICHARD WEX
Assistant Deputy Minister
Law Enforcement and Policing Branch

[52-1-o]

DEPARTMENT OF TRANSPORT

CANADA MARINE ACT

Vancouver Fraser Port Authority — Supplementary letters patent

BY THE MINISTER OF TRANSPORT, INFRASTRUCTURE AND COMMUNITIES

WHEREAS effective January 1, 2008 the port authorities of Vancouver, Fraser River and North Fraser amalgamated to continue as the Vancouver Fraser Port Authority (“Authority”);

WHEREAS letters patent were issued by the Minister of Transport, Infrastructure and Communities for the Authority pursuant to paragraph 59.7(k) of the Port Authorities Management Regulations effective January 1, 2008;

WHEREAS Schedule B of the letters patent describes the federal real property managed by the Authority;

WHEREAS the Authority pursuant to subparagraph 46(1)(b)(i) of the Canada Marine Act (“Act”) wishes to exchange with CN Rail the federal real property described in Annex A hereto for the real property described in Annex B hereto;

AND WHEREAS the board of directors of the Authority has requested that the Minister of Transport, Infrastructure and Communities issue supplementary letters patent to amend Schedule B of its letters patent to reflect this exchange of lands;

NOW THEREFORE under the authority of section 9 of the Act, the letters patent are amended by:

• removing from paragraph 1 of Schedule B of the letters patent the federal real property described in Annex A hereto, by adding these properties as clause (c) to the paragraph commencing with “and also excluding:” described in the part of the letters patent commencing with “All bed and Foreshore of the Fraser and Pitt Rivers”;
• adding the real property described in Annex B hereto to the list of federal real property in paragraph 2 of Schedule B of the letters patent after PID number 026-137-887.

These supplementary letters patent are to be effective on the later of:

(i) the date of registration in the New Westminster Land Title Office of the transfer documents evidencing the transfer of the federal real properties from Her Majesty the Queen in right of Canada to CN Rail; and

(ii) the date of registration in the New Westminster Land Title Office of the transfer documents evidencing the transfer of the real properties from CN Rail to Her Majesty the Queen in right of Canada.

If both transfers identified in (i) and (ii) above are registered on the same date, these supplementary letters patent are to be effective on the date of registration.

Issued under my hand this 9th day of December 2009.

____________________________________________
John Baird, P.C., M.P.
Minister of Transport, Infrastructure and Communities

ANNEX A

ANNEX B

[52-1-o]